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 VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction (NCT02112877), a non-randomized na study. The primary outcome is Number of Participants With Major Adverse Events (MAE).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02112877 |
| Phase | NA |
| Condition | Chronic Venous Disorder, Venous Outflow Obstruction, Symptomatic Venous Outflow Obstruction of Iliofemoral Vein |
| Allocation | Non-Randomized |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 200 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boston Scientific Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with clinically significant chronic, non-malignant obstruction of the iliofemoral venous segment. The registry lists chronic venous disorder and symptomatic venous outflow obstruction among the conditions. It describes feasibility and pivotal cohorts; the pivotal cohort’s primary-endpoint population excludes one subject who never returned for follow-up after discharge.
Intervention
The intervention was percutaneous implantation of the Veniti Vici Venous Stent System in the common femoral vein, external iliac vein and/or common iliac vein. The record describes the study as prospective, multi-center, single-arm and non-randomized.
Comparator
There was no randomized control group. Feasibility and pivotal are the two cohorts described in the record, but they are not a like-for-like treatment comparison. Both involved the Vici stent system, and differences between their reported figures cannot be interpreted as effects of different treatments.
Primary question
The primary safety endpoint asks how many participants experienced a major adverse event within 30 days, with events adjudicated by a Clinical Events Committee. The registry record describes this endpoint but does not report its result. The study also lists improvement in Venous Clinical Severity Score as a secondary outcome, but a result for that outcome is not reported in the registry record.
3. Trial Design
VIRTUS was a prospective, multi-center, single-arm, non-randomized device study. Its stated purpose was to evaluate safety and efficacy of the Vici Venous Stent System in relation to pre-defined objective performance goals. The registry describes a feasibility cohort and a pivotal cohort; both received percutaneous stent implantation. Because there was no randomized comparator, these cohorts do not provide a like-for-like control comparison.
The registry planned enrollment of a maximum of 200 patients. Its summary describes 30 feasibility patients at approximately 7-10 centers and 170 pivotal patients at approximately 45 centers worldwide. The study record lists enrollment as 200. It gives a follow-up period of 36 months, while the primary safety endpoint has a 30-day timeframe. The primary endpoint concerns major adverse events adjudicated by a Clinical Events Committee.
The study is listed as completed. Its recorded start date is 2014-06-26, and its primary completion date is 2017-12-05. The phase is listed as not applicable. The record identifies Boston Scientific Corporation as the sponsor. Masking is listed as none, and the design model as sequential. Further detail on the sequence or conduct of enrollment is not reported in the registry record.
The registry record does not report the objective performance-goal values or explain how they were set. It also does not report the protocol’s statistical plan, sample-size justification, or any interim analysis plan. Those omissions limit assessment of how the study’s planned criteria relate to its posted results.
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.
Before assignment: A total of 200 subjects have been enrolled in the VIRTUS Trial, including 30 subjects in the feasibility cohort and 170 subjects in the pivotal cohort.
Overall Study
| Stage | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| STARTED | 30 | 170 |
| COMPLETED | 28 | 157 |
| NOT COMPLETED | 2 | 13 |
Reasons for not completing this period:
| Reason | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|
| Withdrawal by Subject | 1 | 7 |
| Visit Missed | 1 | 6 |
Analysis population for the primary outcome, as defined in the registry: For the pivotal cohort, one subject never returned for follow-up after discharge.
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 | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal | Total |
|---|---|---|---|---|
| Participants analysed | 30 | 170 | 200 | |
| Age, Continuous | years | 44.4 (SD 14.3) | 54.4 (SD 16.2) | 52.9 (SD 16.3) |
| Sex: Female, Male: Female | Participants | 24 | 96 | 120 |
| Sex: Female, Male: Male | Participants | 6 | 74 | 80 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Asian | Participants | 2 | 5 | 7 |
| Race/Ethnicity, Customized: Black or African American | Participants | 1 | 20 | 21 |
| Race/Ethnicity, Customized: Native Hawaiian or Pacific Islander | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: White | Participants | 25 | 127 | 152 |
| Race/Ethnicity, Customized: White African | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Latin American | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: Not Answered | Participants | 0 | 14 | 14 |
| Race/Ethnicity, Customized: North African | Participants | 2 | 0 | 2 |
| Race/Ethnicity, Customized: Hispanic or Latino | Participants | 2 | 13 | 15 |
| Race/Ethnicity, Customized: Not Hispanic or Latino | Participants | 25 | 141 | 166 |
| Region of Enrollment: Netherlands | Participants | 1 | 0 | 1 |
| Region of Enrollment: United States | Participants | 8 | 119 | 127 |
| Region of Enrollment: Ireland | Participants | 3 | 5 | 8 |
| Region of Enrollment: United Kingdom | Participants | 10 | 22 | 32 |
| Region of Enrollment: France | Participants | 3 | 18 | 21 |
| Region of Enrollment: Germany | Participants | 0 | 5 | 5 |
| Region of Enrollment: Spain | Participants | 5 | 1 | 6 |
| Chronic Non-Malignant Obstruction: Left Leg | Participants | 24 | 145 | 169 |
| Chronic Non-Malignant Obstruction: Right Leg | Participants | 5 | 24 | 29 |
| Chronic Non-Malignant Obstruction: Both Legs | Participants | 1 | 1 | 2 |
| Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment: 0 (No visible or palpable signs of venous disease | Participants | 1 | 2 | 3 |
| Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment: 1 (Telangiectasia or reticular veins) | Participants | 0 | 0 | 0 |
| Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment: 2 (Varicose Veins) | Participants | 0 | 2 | 2 |
| Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment: 3 (Edema) | Participants | 13 | 45 | 58 |
| Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment: 4 (Skin changes ascribed to venous disease) | Participants | 13 | 78 | 91 |
| Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment: 5 (Healed ulceration) | Participants | 2 | 22 | 24 |
| Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment: 6 (Active ulceration) | Participants | 1 | 21 | 22 |
| Venous Clinical Severity Score (VCSS) Leg Pain (Target Limb): Absent | Participants | 2 | 15 | 17 |
| Venous Clinical Severity Score (VCSS) Leg Pain (Target Limb): Mild | Participants | 2 | 35 | 37 |
| Venous Clinical Severity Score (VCSS) Leg Pain (Target Limb): Moderate | Participants | 17 | 54 | 71 |
| Venous Clinical Severity Score (VCSS) Leg Pain (Target Limb): Severe | Participants | 9 | 42 | 51 |
| Diabetic | Participants | 2 | 29 | 31 |
| Smoking History: Current Smoker | Participants | 3 | 21 | 24 |
| Smoking History: Former Smoker | Participants | 8 | 41 | 49 |
| Smoking History: Non-Smoker | Participants | 19 | 108 | 127 |
| History of Pulmonary Embolism (PE) | Participants | 2 | 28 | 30 |
| History of Deep Vein Thrombosis (DVT) | Participants | 19 | 119 | 138 |
| History of Coronary Artery Disease (CAD) | Participants | 0 | 14 | 14 |
| History of Myocardial Infarction (MI) within past 5 years | Participants | 0 | 1 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Major Adverse Events (MAE), measured over 30 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with a major adverse event within 30 days. It is defined as a composite safety endpoint, with events adjudicated by a Clinical Events Committee. A composite endpoint combines multiple event types into a single outcome; its interpretation depends on which events qualify and how they are assessed. The registry record does not list the component events or report the endpoint result.
Counting participants with an event is different from counting every event. A participant who experiences multiple qualifying events may still contribute as a participant with an event, depending on the endpoint’s rules. The record specifies a participant-count measure but does not provide further rules about handling repeated events.
General: A defined safety endpoint can give a study a consistent way to assess whether serious harms occurred during a stated observation period. Adjudication can support consistency in deciding whether reported events meet endpoint criteria. However, the endpoint’s definition alone does not show how frequently events occurred, whether they were related to the device, or how the result compares with a benchmark. The primary result and the objective performance goals are not reported in the registry record, so those questions cannot be answered from the endpoint description.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a single-arm evaluation rather than a randomized comparison. Its feasibility and pivotal cohorts both received the Vici stent system. Therefore, the cohort figures do not estimate a treatment contrast against an untreated group or another device, and they should not be read as evidence that one cohort did better because of a treatment difference.
The stated primary endpoint is major adverse events within 30 days, adjudicated by a Clinical Events Committee. Its result is not reported in the registry record. In particular, the record does not give a primary-endpoint event count, an estimate of the event rate, a confidence interval, a comparison with an objective performance goal, or an inferential test for that endpoint. The registry lists a secondary outcome of improvement in Venous Clinical Severity Score, but its result is also not reported in the registry record.
The safety information does include participant counts for serious and other adverse events in the feasibility and pivotal cohorts. These counts describe participants with reported events; they are not the primary endpoint result unless the registry explicitly establishes that equivalence, which it does not. The record also lists deaths by cohort. The posted figures alone do not establish whether an event was caused by the device or procedure, how events overlapped within participants, or how events relate to the primary endpoint. The registry record does not report those details.
General: An estimate is more informative when accompanied by a confidence interval, which conveys the range of values compatible with the data under the statistical model. A point estimate alone does not show precision. No confidence interval for the primary endpoint is reported in the registry record, so its precision cannot be assessed from the primary result. The record also does not report a statistical analysis comparing the observed endpoint with the objective performance goals.
The registry describes a planned maximum enrollment and cohort targets, but enrollment alone does not establish the precision of an endpoint estimate. The sample-size illustrations use the observed effect and specified planning assumptions; they are planning calculations, not observed power. Since the primary endpoint result and its observed effect are not reported in the registry record, no conclusion about the endpoint’s magnitude or precision can be drawn from those descriptions.
9. Statistical Methods Explained
The registry identifies the study as non-randomized, unmasked, sequential and single-arm. These are design descriptions, not statistical results. Allocation was not randomized, and the record does not describe a concurrent control group. The feasibility and pivotal cohorts are both intervention cohorts, so a direct numerical contrast between them would not have the protection against confounding that random allocation can provide.
What does a single-arm design tell us?
General: In a single-arm study, observed outcomes describe participants who received the intervention. Without a suitable comparison group, the outcomes cannot by themselves separate the intervention’s contribution from other influences, such as participant characteristics, clinical care, or the natural course of the condition. A comparison against a pre-defined performance goal can address a different question, but interpreting it requires knowing the goal, the analysis method, and the observed result. The goals and their statistical treatment are not reported in the registry record.
What does the primary measure count?
The primary outcome is a count of participants with a major adverse event in the 30-day timeframe. General: A participant-level binary outcome classifies each participant as having or not having the event under the endpoint definition. This differs from counting total events, since one participant may experience more than one event. The registry specifies the participant-count measure, but does not report the primary result or detailed rules for multiple events, missing assessments, or endpoint adjudication beyond naming the Clinical Events Committee.
How should uncertainty be understood?
General: Statistical estimates are subject to sampling variability. A confidence interval is a range calculated using a specified method to express uncertainty around an estimate; narrower intervals generally indicate greater precision under that method. A significance test addresses compatibility with a specified null hypothesis, not clinical importance or causality. The registry record does not report a primary-endpoint confidence interval, test, or analysis method, so none should be inferred.
What do the planning assumptions mean?
The sample-size assumptions describe planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. The record specifies that time-to-event illustrations give the total number of events, while other illustrations give participants per arm. These are planning calculations, not observed power and not the number of participants or events actually observed. The primary endpoint result and observed effect are not reported in the registry record, so the illustrations should not be treated as evidence about the endpoint’s outcome.
General: Sample-size calculations depend on assumptions about the effect to detect, variability or event frequency, allocation, and analysis method. A calculation can illustrate the scale of a future study under stated assumptions, but it cannot establish that a completed study had adequate precision or that a result is persuasive. The record does not report the original design justification, so the listed planning assumptions should not be taken as a complete account of the study’s original design process.
Why does over-dispersion matter in general?
General: When count outcomes vary more than a statistical model assumes, standard errors from that model can be too small. This is called over-dispersion and can make confidence intervals too narrow and tests too optimistic. It is relevant to count-data analyses when the model and data have that structure. The primary endpoint in this record is described as participants with an event, and the registry does not report a count-data model or an over-dispersion assessment. No claim about over-dispersion in this study is therefore warranted.
The registry lists no analyses. It does not report the statistical analysis plan, methods for missing data, adjustment for multiplicity, or analysis populations beyond the note that one subject in the pivotal cohort never returned for follow-up after discharge. Consequently, the planned analysis cannot be reconstructed from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists ten outcome measures and no analyses. It identifies the primary safety endpoint and lists improvement in Venous Clinical Severity Score as a secondary outcome, but does not report results for either in the record. A multiplicity strategy for interpreting multiple outcomes or tests is not reported in the registry record.
General: When several outcomes or hypotheses are examined, the chance of at least one apparently positive finding can rise if each is assessed separately without an adjustment or a pre-specified hierarchy. Whether that matters depends on the analysis plan and the claims being made. The registry does not provide enough information to determine how multiplicity was addressed, so no adjustment should be assumed.
For the pivotal cohort’s primary-endpoint population, the registry notes that one subject never returned for follow-up after discharge. It does not explain how that subject was handled in the endpoint analysis, whether any endpoint information was available, or what missing-data method was used. The corresponding details for other outcomes are not reported in the registry record.
General: Missing outcome information can affect an estimate if the participants without measurements differ from those with observed data. Common approaches depend on the outcome, timing and assumptions about why data are missing. Without the analysis population, missingness rules and sensitivity analyses, readers cannot assess how much the missing follow-up might affect the result. The registry record does not report an intention-to-treat or per-protocol population definition, nor does it report a missing-data sensitivity analysis.
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 |
|---|---|---|---|
| VICI Stent Implantation - Feasibility | 14 | 30 | 46.7% |
| VICI Stent Implantation - Pivotal | 86 | 170 | 50.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| VICI Stent Implantation - Feasibility | 0 of 30 |
| VICI Stent Implantation - Pivotal | 4 of 170 |
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 |
|---|---|
| VICI Stent Implantation - Feasibility | 14 of 30 |
| VICI Stent Implantation - Pivotal | 102 of 170 |
Most frequent serious adverse event terms
| Event term | Organ system | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | 2 of 30 | 17 of 170 |
| Vascular stent thrombosis | General disorders | 4 of 30 | 10 of 170 |
| Venous angioplasty | Surgical and medical procedures | 4 of 30 | 9 of 170 |
| Vascular stent restenosis | General disorders | 2 of 30 | 8 of 170 |
| Cellulitis | Infections and infestations | 0 of 30 | 8 of 170 |
| Vascular stent stenosis | General disorders | 2 of 30 | 4 of 170 |
| Varicose vein operation | Surgical and medical procedures | 2 of 30 | 4 of 170 |
| Sepsis | Infections and infestations | 0 of 30 | 6 of 170 |
| Venous stent insertion | Surgical and medical procedures | 3 of 30 | 2 of 170 |
| Back pain | Musculoskeletal and connective tissue disorders | 0 of 30 | 5 of 170 |
Most frequent non-serious adverse event terms
| Event term | Organ system | VICI Stent Implantation - Feasibility | VICI Stent Implantation - Pivotal |
|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 2 of 30 | 17 of 170 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 30 | 15 of 170 |
| Peripheral swelling | General disorders | 0 of 30 | 16 of 170 |
| Peripheral venous disease | Vascular disorders | 0 of 30 | 16 of 170 |
| Vascular stent thrombosis | General disorders | 1 of 30 | 5 of 170 |
| Nausea | Gastrointestinal disorders | 1 of 30 | 4 of 170 |
| Abdominal pain | Gastrointestinal disorders | 0 of 30 | 5 of 170 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 0 of 30 | 5 of 170 |
| Fall | Injury, poisoning and procedural complications | 1 of 30 | 3 of 170 |
| Paraesthesia | Nervous system disorders | 1 of 30 | 3 of 170 |
Serious events with the highest arm-level rate: vascular stent thrombosis (13.3%), venous angioplasty (13.3%), venous stent insertion (10.0%), deep vein thrombosis (10.0%), vascular stent restenosis (6.7%).
The registry reports participants with serious adverse events and participants with other adverse events separately for the feasibility and pivotal cohorts. For serious adverse events, the posted counts are 14 of 30 in the feasibility cohort and 86 of 170 in the pivotal cohort. For other adverse events, the counts are 14 of 30 and 102 of 170, respectively. These are participant counts, not totals of every event, and the groups are not randomized comparison arms.
The record lists 0 deaths in the feasibility cohort and 4 in the pivotal cohort. It does not state in these figures whether the deaths were related to the device or procedure. The listed serious-event terms include vascular stent thrombosis and venous angioplasty, each reported as 13.3%; venous stent insertion and deep vein thrombosis, each reported as 10.0%; and vascular stent restenosis and vascular stent stenosis, each reported as 6.7%. The registry record does not give the denominator or further context for those term percentages.
These safety figures should not be substituted for the primary endpoint. The primary endpoint is specifically major adverse events within 30 days, adjudicated by a Clinical Events Committee, while the reported adverse-event counts are not identified as that adjudicated endpoint. Event overlap, timing beyond the endpoint description, and causal attribution are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes the study’s design and the endpoint it intended to assess: a composite of major adverse events within 30 days, adjudicated by a Clinical Events Committee. It also gives cohort descriptions and safety counts for serious and other adverse events. These registry entries describe what was studied and what safety information is posted; they do not supply the primary endpoint result.
The registry record does not report the number of participants meeting the primary endpoint, its estimate or uncertainty, or a comparison with the stated objective performance goals. It also does not report the result for the secondary outcome of improvement in Venous Clinical Severity Score. Consequently, the record cannot support a conclusion about the frequency of the primary endpoint or how it relates to the study’s performance goals.
General: A single-arm study can describe outcomes among participants who received an intervention. Without a suitable control comparison, it cannot by itself establish what would have happened to similar participants under another treatment or without the intervention. Here, feasibility and pivotal are cohorts within a non-randomized study, not randomized treatment groups.
The adverse-event counts and deaths should be interpreted as posted safety information, not as proof of device causation or as a complete substitute for the primary endpoint. The registry does not report the relationship of those events to the device or procedure, nor does it explain how serious adverse-event reporting aligns with the adjudicated primary endpoint. The presence of event terms and counts does not alone answer those questions.
The record also does not give confidence intervals or a statistical analysis for the primary endpoint. As a result, its precision and statistical compatibility with any benchmark cannot be evaluated from the registry record. The available information supports a description of the study design and reported safety counts, but not a claim that the device did or did not meet the study’s safety or efficacy objectives.
13. Why This Trial Matters Statistically
VIRTUS illustrates why study design and outcome reporting need to be read together. The registry describes a prospective, multi-center device study with feasibility and pivotal cohorts, a specified 30-day safety endpoint, and a stated intention to evaluate outcomes against pre-defined objective performance goals. Those features clarify the study’s question, but the primary endpoint result and the goals themselves are not reported in the registry record.
The non-randomized, single-arm design is statistically important. It permits description of observed outcomes among participants receiving the device, but the two cohorts do not constitute a randomized control comparison. A difference between their reported counts would not isolate a treatment effect, and the record does not report a formal comparison between them.
The registry also illustrates a distinction between safety summaries and a defined primary endpoint. Serious and other adverse-event participant counts are available, as are listed serious-event terms and deaths. Yet those figures are not explicitly identified as the adjudicated primary endpoint, and the record does not establish causal attribution. Readers therefore need to keep outcome definitions, timing and analysis populations separate.
Finally, the absence of a reported primary result, confidence interval, analysis plan and multiplicity approach constrains statistical interpretation. Enrollment targets and planning assumptions do not replace endpoint estimates or measures of uncertainty. The study is informative as a record of design and posted safety information, while the missing primary analysis prevents a statistical assessment of the stated primary question.
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 main limitation for interpreting this record is that the primary endpoint is described but its result is not reported. The registry also does not report the objective performance goals against which the study was intended to evaluate safety and efficacy. Without the result and benchmark, their relationship cannot be assessed.
The study is non-randomized and single-arm. Its feasibility and pivotal cohorts both received the Vici stent system, so neither serves as a randomized control group. The record does not report a comparison that would support attributing differences between cohorts to treatment.
The registry does not report confidence intervals, an inferential analysis for the primary endpoint, the statistical analysis plan, or the method used to address multiplicity. It notes that one subject in the pivotal cohort never returned after discharge, but does not describe how this missing follow-up was handled. Analysis-population definitions and missing-data sensitivity analyses are not reported in the registry record.
The listed adverse-event counts do not establish whether events overlap within participants or whether they were related to the device or procedure. The registry does not explain how these summaries relate to the adjudicated primary endpoint. The serious-event term percentages are posted without denominator context in the record.
The record lists a follow-up period of 36 months, but the primary safety endpoint is limited to 30 days. The longer follow-up description does not itself provide results for later outcomes. The original sample-size justification, interim analysis plan and detailed outcome analysis methods are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction — NCT02112877.
- Registry record last updated 2021-04-15; status last verified 2021-03.
- Results first posted 2019-07-30.
- 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
VIRTUS (NCT02112877) is a completed, prospective, multi-center, single-arm, non-randomized evaluation of the Veniti Vici Venous Stent System for chronic non-malignant iliofemoral venous obstruction. The registry describes feasibility and pivotal cohorts and a follow-up period of 36 months.
The primary endpoint is participants with major adverse events within 30 days, adjudicated by a Clinical Events Committee. Its result and the objective performance goals are not reported in the registry record. A secondary outcome is improvement in Venous Clinical Severity Score; its result is also not reported.
The record posts participant counts for serious and other adverse events, along with deaths and selected serious-event terms. These summaries are not identified as the primary endpoint and do not establish causality. The registry does not report the primary analysis method, confidence intervals, multiplicity approach, or handling of the pivotal participant who did not return for follow-up.