This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for JETi Lower Extremity Arterial Thrombosis (NCT04370691), a registered phase not stated study. The primary outcome is Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04370691 |
| Phase | Phase not stated |
| Condition | Arterial Thrombosis |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 129 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Abbott Medical Devices |
| Results posted | Yes |
2. Clinical Question
Population
The registry concerns subjects treated for acute or subacute thrombosis in the peripheral vasculature. The condition listed is arterial thrombosis, and the primary endpoint focuses on JETi-treated target vessels in the lower extremity. Enrollment was 129. For the endpoint, the registry says the analyzed participant population includes subjects with available follow-up data at the relevant time frame; the number of participants or vessels contributing to the primary endpoint is not reported in the registry record.
Intervention
The intervention was the JETi Hydrodynamic Thrombectomy System, a device used to remove clot. The registry describes the study as a post-market collection of real-world data about the system’s safety, performance, and clinical benefits. The treatment arm included subjects treated with the system. Details about individual procedures, device use, and accompanying care beyond the endpoint’s timing are not reported in the registry record.
Comparator
There was no randomized comparator group. The registry is described as single-arm, and the posted design details identify no control arm or allocation method. The primary endpoint compares angiographic clot-removal grades before and after JETi treatment within treated target vessels. That is a before-and-after assessment, not a comparison between independently assigned treatment groups.
Primary question
The primary question is how clot-removal grade for each JETi-treated target vessel changes from the pre-JETi angiogram to the post-JETi angiogram. The post-treatment image is assessed after thrombectomy and before adjunctive therapies for underlying culprit lesions. An independent imaging core laboratory assesses the endpoint. Grades classify the degree of reduction into three categories: Grade I, less than 50%; Grade II, 50 to less than 95%; and Grade III, 95–100%. The registry record does not report the observed counts in these grades, so the magnitude and distribution of the endpoint result cannot be described.
3. Trial Design
The JETi Enhanced Thrombectomy Intervention Registry is described as a prospective, single-arm, multi-center, post-market study. It was intended to collect real-world information on safety, performance, and clinical benefits of the JETi Hydrodynamic Thrombectomy System for acute or subacute thrombosis in the peripheral vasculature. The listed intervention is a device, and the arm description says that subjects treated with the JETi system were included. There is no randomized comparison in the registry design details.
The registry summary described a plan to register approximately 280 subjects at approximately 30 centers globally and to follow participants through the 12-month follow-up visit. Actual enrollment is listed as 129. The record status is completed, with a start date of 2020-03-06 and a primary completion date of 2024-01-16. These registry entries describe the registry’s status and enrollment; they do not establish how many participants completed each visit or contributed data to each outcome.
The primary endpoint is a per-vessel assessment of angiographic clot-removal grade from before JETi treatment to after thrombectomy. The post-JETi assessment is defined as occurring before any adjunctive therapies for underlying culprit lesions, and an independent imaging core laboratory is responsible for assessment. The endpoint time frame is labeled Baseline. The registry record does not report a randomized allocation process, a control group, or the clinical and statistical protocol details needed to explain the endpoint’s analysis beyond this description.
The registry record lists two outcome measures and no analyses. A detailed description of the primary outcome is available in the record details, but additional outcome details and analysis results are not reported in the registry record. Because the design is single-arm, the primary before-and-after vessel assessment can describe angiographic changes around treatment, but it does not by itself provide a randomized estimate of what would have happened without the device.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | JETi™ Hydrodynamic Thrombectomy System |
|---|---|
| STARTED | 129 |
| COMPLETED | 42 |
| NOT COMPLETED | 87 |
Reasons for not completing this period:
| Reason | JETi™ Hydrodynamic Thrombectomy System |
|---|---|
| Pending visit | 48 |
| Have Not Reached Lower Window | 15 |
| Termination | 14 |
| Missed or Overdue | 10 |
Analysis population for the primary outcome, as defined in the registry: The number of participants analyzed includes subjects who had available follow up data at that time frame.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | JETi™ Hydrodynamic Thrombectomy System |
|---|---|---|
| Participants analysed | 129 | |
| Age, Continuous | years | 66.9 (SD 12.0) |
| Sex: Female, Male: Female | Participants | 47 |
| Sex: Female, Male: Male | Participants | 82 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 74 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 52 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 1 |
| Race/Ethnicity, Customized: Asian | Participants | 2 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race/Ethnicity, Customized: Black or African American | Participants | 9 |
| Race/Ethnicity, Customized: White | Participants | 64 |
| Race/Ethnicity, Customized: Others | Participants | 3 |
| Race/Ethnicity, Customized: Unknown or Not Reported | Participants | 50 |
| Acute Limb Ischemia | Participants | 68 |
| Acute Limb Ischemia: In-Stent thrombosis | Participants | 13 |
| Acute Limb Ischemia: Acute graft thrombosis | Participants | 12 |
| Peripheral Artery Disease with Claudication (Rutherford 1-3) | Participants | 15 |
| Peripheral Artery Disease with CLTI (Rutherford 4-5) | Participants | 21 |
6. Primary Endpoint
The registry lists the primary outcome as Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis, measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Count Of Units |
| Measure of spread | not applicable |
| Unit | Vessels |
| Endpoint classification | not reduced to a single comparison |
The primary effectiveness endpoint classifies the degree of clot removal for each JETi-treated target vessel by comparing a pre-JETi angiogram with a post-JETi angiogram. The latter image is taken after thrombectomy and before adjunctive therapies intended to treat underlying culprit lesions. An independent imaging core laboratory assesses the images. The unit is vessels, rather than participants, so the endpoint is defined at the vessel level and should not be interpreted automatically as a count of people.
The grade system divides the observed reduction into three ordered categories: Grade I is less than 50% reduction; Grade II is 50 to less than 95% reduction; and Grade III is 95–100% reduction. The categories offer a structured way to describe the degree of angiographic clot reduction, rather than treating all changes as equivalent. The endpoint is used to assess immediate angiographic clot removal following the device procedure. Separating this assessment from adjunctive treatment helps define what is being evaluated at the post-treatment imaging point; it does not establish that any observed change was caused solely by the device.
The registry record does not report the numbers of vessels in each grade, the number of vessels assessed, or a summary estimate for the primary endpoint. It therefore does not support a numerical description of the endpoint result or its precision. The population note says that participants analyzed include subjects with available follow-up data at the time frame, but endpoint-specific missingness and the number contributing to the per-vessel assessment are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a single-arm study and identifies a vessel-level before-and-after angiographic endpoint. The registry entries do not include the observed distribution of clot-removal grades or a numerical summary of the primary endpoint. Without those outcome results, it is not possible to state how many vessels fell into each grade, characterize the size of the observed change, or assess how precisely that result was estimated. The endpoint definition alone describes what investigators planned to measure; it is not itself evidence of a particular result.
The design also sets a limit on causal interpretation. A comparison of images before and after treatment documents change across those imaging points, but there is no randomized control group identified in the registry entries. General statistical principle: without a suitable comparison group, changes may reflect influences other than the intervention, and a before-and-after assessment cannot separate those influences with the same strength as a randomized comparison. This does not invalidate a descriptive registry; it means the results answer a more limited question than a randomized treatment comparison would.
The timing is specifically defined: the post-JETi angiogram follows thrombectomy and precedes adjunctive therapies for underlying culprit lesions. This definition makes the target of the endpoint clearer, but it does not supply the actual imaging findings. The endpoint’s stated time frame is Baseline, while the registry summary also describes follow-up through the 12-month visit. The record details do not clarify how the endpoint time-frame label relates to later follow-up measurements, and the primary endpoint description is focused on the immediate pre- and post-JETi angiograms.
Safety information is presented as counts of affected subjects and deaths, with 129 at risk for both serious and other adverse events. The registry lists 28 as affected by serious adverse events, 16 as affected by other adverse events, and 7 deaths. These are descriptive safety figures. The record details do not give event-level timing, relatedness, severity breakdowns beyond the serious/other grouping, or enough detail to determine whether categories overlap. The serious adverse-event terms with the largest listed percentages include Peripheral Artery Thrombosis at 6.2%, Death at 3.9%, Arterial Restenosis at 3.9%, Peripheral Ischaemia at 3.9%, Infection at 3.1%, and Limb Amputation at 3.1%. Those term percentages should be read as listed, not as a complete account of all safety outcomes.
No inferential analyses are listed. Confidence intervals, hypothesis tests, adjusted estimates, and subgroup results for the primary endpoint are not reported in the registry record. General statistical principle: a confidence interval communicates the range of values reasonably compatible with an estimate under the analysis assumptions; without an estimate and interval, precision cannot be judged. The enrollment of 129 is not a substitute for endpoint-specific denominators or uncertainty estimates, especially because the primary endpoint is measured per vessel and the analyzed population may depend on data availability.
The registry’s planned enrollment was approximately 280, while actual enrollment is 129. Those figures describe a difference between the stated plan and recorded enrollment, not the reason for it or its consequences for the study’s objectives. The registry record does not report a sample-size justification, a revised target, or an account of recruitment. The sample-size material described for the page is a planning illustration based on an observed effect, not the registry’s original design; no numerical illustration results are included in the registry record used for this explanation. Such illustrations are not observed power and do not replace the study’s own analysis.
9. Statistical Methods Explained
The primary outcome is a categorical grade assessed for each treated vessel. It is not a continuous measure reported as a single numeric reduction, and its three ordered categories represent ranges of angiographic clot reduction. Grade I is less than 50% reduction, Grade II is 50 to less than 95% reduction, and Grade III is 95–100% reduction. The ordered structure means that a higher grade corresponds to a category with greater clot reduction as defined by the registry. The registry entries do not report how the categories were summarized statistically or whether any other endpoint representation was used.
General statistical explanation: categorical outcomes are commonly described using counts and proportions in each category. When categories are ordered, an analysis may also make use of that ordering, but the particular method needs to be specified. The registry entries identify the endpoint type as a count of units and give no analysis entries. Therefore, no particular model, test, or summary method can be attributed to this study from the available record details. Counts of vessels would also need to be interpreted in light of how many vessels were assessed and whether multiple vessels could come from one participant; those details are not reported in the registry record.
The imaging core laboratory is identified as the assessor. General statistical explanation: independent image assessment can help standardize endpoint classification and reduce the influence of the treating team’s expectations, but it does not remove every source of measurement error. The record details do not report assessor blinding, procedures for resolving disagreements, training or reproducibility measures, or whether image assessments were available for every treated vessel. Those features should not be assumed.
The primary endpoint compares pre- and post-treatment images from the same target vessel. General statistical explanation: paired observations are related because both measurements concern the same unit. Analyses of paired data should account for that relationship rather than treating pre- and post-treatment observations as if they came from unrelated units. The registry record does not report the method used to summarize or test the paired grades. It also does not provide the actual grade results, so no effect estimate or uncertainty can be explained for this endpoint.
The study is single-arm. General statistical explanation: a single-arm registry can describe outcomes observed among treated participants and can document patterns of safety events. In the absence of a randomized control group, it does not directly estimate a between-group treatment effect. A pre/post change is a within-vessel description and may be affected by the timing of imaging, selection of vessels, accompanying care, and other influences. The registry entries do not establish the extent of any such influences, nor do they report an adjustment strategy.
The record lists 129 enrolled participants, but the primary endpoint is analyzed per vessel. General statistical explanation: the number of participants and the number of measured units can differ, and multiple units within one participant may be statistically related. A valid analysis may need to account for that clustering if multiple vessels are included per participant. The registry entries do not report the number of vessels, the number of vessels per participant, or whether an analysis accounted for clustering. Consequently, the enrollment count alone cannot identify the precision of a vessel-level estimate.
No statistical analyses are listed in the registry entries. In particular, estimates, confidence intervals, p-values, adjusted models, and subgroup analyses are not reported in the registry record. General statistical explanation: an estimate describes the observed quantity, while an uncertainty interval helps show how much sampling uncertainty surrounds it under the model. A p-value, when used, addresses compatibility with a specified null model and is not a measure of clinical importance. None of these inferential quantities can be reconstructed from endpoint definitions or enrollment counts alone.
The sample-size assumptions associated with the planning illustration specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. For time-to-event examples, the illustration gives total events using the Schoenfeld approach; other examples give participants per arm. These are planning assumptions for illustrations, not the registry’s single-arm design or its observed findings. The numerical sample-size results and the effect fractions are not reported in the registry entries. General statistical explanation: sample-size planning depends on assumptions about the target effect, variability or event frequency, design, and error rates. If those assumptions differ from the eventual study, the planning figure may not describe the precision actually achieved. A planning calculation is not observed power.
Dispersion is not specified for this primary outcome. General statistical explanation: over-dispersion occurs when observed variability is greater than a model assumes; if unaccounted for, standard errors may be too small and uncertainty may appear narrower than warranted. Whether over-dispersion is relevant depends on the outcome and the chosen model. Since the registry entries do not identify a fitted model or dispersion estimate, it is not possible to say that over-dispersion was assessed or that a particular correction was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry entries identify two outcome measures and no analyses. A detailed primary endpoint description is available, but the other outcome measure’s details and results are not reported in the registry record. No analysis plan describing which outcomes were primary or secondary beyond the primary endpoint title, or how multiple comparisons would be handled, is reported. Multiplicity procedures, such as an adjustment to control the chance of false-positive findings across several tests, are not reported in the registry record. Since no inferential analyses are listed, there are no reported p-values or confidence intervals to interpret in light of multiple testing.
The endpoint population note states that the number of participants analyzed includes subjects who had available follow-up data at that time frame. It does not give the number with available primary endpoint assessments, the number missing, reasons for missingness, or methods for handling missing images or incomplete follow-up. The endpoint is defined per vessel, while the population note is phrased in terms of participants; the record details do not explain how missing participant-level follow-up maps to missing vessel-level assessments.
The registry summary planned follow-up through the 12-month visit, but completion rates at that visit and the amount of missing follow-up are not reported in the registry record. The endpoint time frame is labeled Baseline, and the registry entries do not specify whether later time points contribute to the primary analysis. No imputation approach, sensitivity analysis, or missing-data assumption is reported. General statistical explanation: missingness can affect interpretation when the probability of an outcome being observed is related to participant characteristics or outcomes. The available information does not establish whether that concern arose or how it was addressed.
The record lists enrollment of 129, but this does not establish the endpoint analysis denominator. The number of vessels assessed, exclusions from analysis, and analysis population definitions beyond the available-follow-up note are not reported in the registry record. These omissions limit assessment of completeness and make it inappropriate to treat the enrollment figure as the denominator for the primary endpoint.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| JETi™ Hydrodynamic Thrombectomy System | 28 | 129 | 21.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| JETi™ Hydrodynamic Thrombectomy System | 7 of 129 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| JETi™ Hydrodynamic Thrombectomy System | 16 of 129 |
Most frequent serious adverse event terms
| Event term | Organ system | JETi™ Hydrodynamic Thrombectomy System |
|---|---|---|
| Peripheral Artery Thrombosis | Vascular disorders | 8 of 129 |
| Death | General disorders | 5 of 129 |
| Arterial Restenosis | Injury, poisoning and procedural complications | 5 of 129 |
| Peripheral Ischaemia | Vascular disorders | 5 of 129 |
| Infection | Infections and infestations | 4 of 129 |
| Limb Amputation | Surgical and medical procedures | 4 of 129 |
| Chest Pain | General disorders | 3 of 129 |
| Vascular Graft Occlusion | Injury, poisoning and procedural complications | 3 of 129 |
| Haemorrhage | Vascular disorders | 3 of 129 |
| Cardiac Failure | Cardiac disorders | 2 of 129 |
Most frequent non-serious adverse event terms
| Event term | Organ system | JETi™ Hydrodynamic Thrombectomy System |
|---|---|---|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | 5 of 129 |
| Arterial Restenosis | Injury, poisoning and procedural complications | 4 of 129 |
| Peripheral Swelling | General disorders | 1 of 129 |
| Cellulitis | Infections and infestations | 1 of 129 |
| Rectal Abscess | Infections and infestations | 1 of 129 |
| Vascular Access Site Infection | Infections and infestations | 1 of 129 |
| Post Procedural Haematoma | Injury, poisoning and procedural complications | 1 of 129 |
| Vascular Access Site Haematoma | Injury, poisoning and procedural complications | 1 of 129 |
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | 1 of 129 |
| Wound Complication | Injury, poisoning and procedural complications | 1 of 129 |
Serious events with the highest arm-level rate: peripheral artery thrombosis (6.2%), death (3.9%), arterial restenosis (3.9%), peripheral ischaemia (3.9%), infection (3.1%).
The safety details list 129 at risk for serious adverse events and 129 at risk for other adverse events in the JETi treatment group. The count shown as affected is 28 for serious adverse events and 16 for other adverse events. Deaths are listed separately as 7. These are descriptive counts from the registry; the record details do not specify whether the serious, other, and death categories overlap or how events were attributed to treatment.
The highest listed serious adverse-event terms and their reported percentages are Peripheral Artery Thrombosis, 6.2%; Death, 3.9%; Arterial Restenosis, 3.9%; Peripheral Ischaemia, 3.9%; Infection, 3.1%; and Limb Amputation, 3.1%. These listed terms are not a complete event narrative. The registry entries do not report the timing, duration, outcome, or relatedness assessment for each event, nor do they provide a breakdown by severity beyond the serious and other adverse-event groupings.
General statistical explanation: safety counts describe events observed in the registry population and are not, by themselves, evidence that an event was caused by a device. Interpreting event rates also depends on follow-up duration, completeness of reporting, and the rules for counting repeated events or participants with multiple events. Those details are not reported in the registry record. The stated 12-month follow-up plan should not be taken to mean that every participant completed that follow-up; completion data are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry is designed to collect real-world information about use of the JETi Hydrodynamic Thrombectomy System in peripheral arterial thrombosis. Its primary endpoint specifies a pre- and post-thrombectomy angiographic assessment of clot-removal grade in treated vessels, with images assessed by an independent core laboratory. This definition makes the intended measurement clear, but the registry entries do not include the observed grade counts or a numerical primary endpoint result. No conclusion about the size or precision of an observed effect can therefore be drawn from the available outcome information.
The record also includes safety counts: 28 affected by serious adverse events, 16 affected by other adverse events, and 7 deaths, with 129 at risk in each of the serious and other adverse-event groups. Serious adverse-event terms are listed with percentages. These figures describe events recorded in the treatment group; they do not by themselves establish whether the device caused an event or how the event risk compares with another treatment or no treatment.
The study’s single-arm design is important. A before-and-after assessment can characterize changes in angiographic findings around the procedure, but it is not a randomized comparison. General statistical principle: causal conclusions require a credible comparison that accounts for what would have happened under an alternative. This registry record does not identify such a control group. The results, if available, would therefore need to be interpreted as observational descriptions rather than as a randomized estimate of comparative effect.
Enrollment was 129, compared with a summary plan for approximately 280 subjects. That contrast does not explain why enrollment differed from the plan, whether all enrolled subjects completed follow-up, or what effect enrollment had on precision. The endpoint denominator and missing-data details are not reported in the registry record. Nor are inferential analyses, confidence intervals, or hypothesis tests listed. The meaning of the record is consequently bounded by design and reporting: it documents the study framework and selected safety information, while the primary endpoint findings and their uncertainty are not available in the registry record described.
Nothing in the registry record establishes an individual treatment decision or a comparative clinical benefit. General statistical explanation: observed outcomes in a registry can inform description and generate questions, but they cannot substitute for a controlled comparison when the question concerns relative effects. The registry’s stated purpose is broader real-world data collection, while the primary endpoint is a focused imaging measure; neither should be treated as a complete account of all possible clinical outcomes.
13. Why This Trial Matters Statistically
This registry illustrates how a clinical endpoint can be defined at a level different from the enrollment unit. Enrollment is counted in participants, whereas the primary effectiveness outcome is assessed per treated vessel. That distinction matters because the number of vessels may not equal the number of participants, and observations from multiple vessels in one participant may be related. The registry entries do not report the number of vessels or the handling of within-participant dependence, so readers should not infer endpoint precision from enrollment alone.
The endpoint also demonstrates the value of specifying measurement timing. The post-JETi image is defined as occurring after thrombectomy but before adjunctive therapies for underlying culprit lesions. This clarifies the procedural point being assessed and helps distinguish the immediate imaging outcome from later care. At the same time, a well-defined endpoint is not a reported result: the registry entries do not show the distribution of grades or an estimate of change.
The registry’s single-arm design makes the distinction between description and comparison especially important. A registry can record outcomes under real-world use, but without a control group it cannot directly estimate a randomized between-group effect. General statistical principle: design determines which questions an analysis can answer; sophisticated analysis cannot create a missing randomized comparison. The study can be understood as an observational description of treated subjects, subject to the completeness and detail of the reported data.
Finally, the difference between planned approximate enrollment and recorded enrollment, together with the absence of endpoint-specific denominators and inferential results, highlights why registry status alone is not enough to judge statistical evidence. The record is completed, but the relevant outcome estimates and their uncertainty are not reported in the registry entries. This case underscores the need to distinguish a completed study from a fully reported analysis, and to distinguish planning illustrations from the study’s actual design and results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation is that the primary endpoint’s observed results are not reported in the registry entries. Grade counts, the number of vessels assessed, a summary estimate, and any measure of uncertainty are absent. As a result, the endpoint can be described but not quantitatively interpreted. The record identifies two outcome measures, but further details about the other outcome are not reported in the registry record.
The design is single-arm and has no randomized comparator identified in the registry record. The pre/post vessel assessment is therefore descriptive and cannot by itself isolate the effect of the device from other influences. The registry entries do not report an adjustment strategy, a comparison group, or a detailed protocol for controlling confounding. The endpoint is assessed before adjunctive therapy for underlying culprit lesions, but that timing definition does not remove all potential sources of bias.
Actual enrollment was 129, while the registry summary described approximately 280 subjects as the intended enrollment. The reason for this difference, any change in the enrollment target, and its consequences for precision are not reported in the registry record. Nor are the number of participants completing follow-up, endpoint-specific missingness, exclusions, or missing-data methods. Although the summary describes follow-up through 12 months, completion at that visit is not reported in the registry record.
Further limitations include the lack of listed statistical analyses, confidence intervals, hypothesis tests, subgroup results, detailed outcome definitions beyond the primary endpoint, and information on imaging-assessment reliability. The per-vessel unit also raises questions about the number of vessels per participant and any adjustment for within-participant correlation; these details are not reported in the registry record. Safety counts are presented without event-level timing or relatedness details. These reporting gaps limit both precision assessment and interpretation of the observed safety profile.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: JETi Lower Extremity Arterial Thrombosis — NCT04370691.
- Registry record last updated 2025-06-17; status last verified 2025-06.
- Results first posted 2025-03-03.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The JETi Enhanced Thrombectomy Intervention Registry is a completed, prospective, single-arm, multi-center, post-market study of the JETi Hydrodynamic Thrombectomy System for acute or subacute peripheral thrombosis. The record lists 129 enrolled participants, a start date of 2020-03-06, and a primary completion date of 2024-01-16. Its summary described intended enrollment of approximately 280 subjects at approximately 30 centers globally and follow-up through 12 months.
The primary endpoint is clot-removal grade per JETi-treated target vessel, assessed from pre- to post-JETi angiography by an independent imaging core laboratory. The endpoint results and analysis estimates are not reported in the registry entries. Safety information lists 28 affected by serious adverse events, 16 by other adverse events, and 7 deaths; 129 are listed at risk for each adverse-event grouping. The single-arm design supports descriptive interpretation, not a randomized comparative treatment estimate.