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 LEVANT 2 Safety Registry (NCT01790243), a randomized na study. The primary outcome is Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01790243 |
| Phase | NA |
| Condition | Peripheral Artery Disease, Femoropopliteal Artery Occlusion, Femoropopliteal Stenosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 1189 |
| Arms in the primary outcome | 2 |
| Lead sponsor | C. R. Bard |
| Results posted | Yes |
2. Clinical Question
Population
People treated for stenosis or occlusion of the femoropopliteal arteries. The registry record lists peripheral artery disease, femoropopliteal artery occlusion, and femoropopliteal stenosis among the conditions. Further eligibility details are not reported in the registry record.
Intervention
The Lutonix Drug Coated Balloon, described as a paclitaxel-coated balloon catheter and formerly called the Moxy Drug Coated Balloon.
Comparator
A standard uncoated angioplasty balloon, also described as a PTA catheter. The registry identifies the comparison as randomized, parallel, and unmasked.
Primary question
How many participants in each group had an unanticipated device- or drug-related serious adverse event from the index procedure through 60 months after that procedure? The posted count is 0 for each group.
3. Trial Design
The LEVANT 2 Safety Registry is described in the registry record as a prospective, multicenter study of the Lutonix Drug Coated Balloon for femoropopliteal arteries. Its stated objective concerns long-term performance of the Lutonix balloon compared with percutaneous transluminal balloon angioplasty. The primary outcome posted for this record is a safety measure: the number of participants with unanticipated device- or drug-related serious adverse events through 60 months after the index procedure.
The record labels the allocation randomized, the masking none, and the model parallel. It lists the Lutonix Drug Coated Balloon and the Standard Uncoated Angioplasty Balloon as the groups. Enrollment is recorded as 1189. The arm-level denominators for the primary outcome are 1029 for the Lutonix group and 160 for the standard-balloon group. These are the posted arm counts; further information about participant flow or the analysis population is not reported in the registry record.
The record lists the study as completed. Its start date is 2011-07-20, and its primary completion date is 2015-11-27. The study phase is recorded as NA. Additional details on the randomization procedure, site-level enrollment, eligibility criteria, follow-up completion, and protocol conduct are not reported in the registry record. The available information therefore describes the recorded design labels and outcomes, but does not establish how each design feature was implemented.
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 | Lutonix Drug Coated Balloon | Standard Uncoated Angioplasty Balloon |
|---|---|---|
| STARTED | 1029 | 160 |
| COMPLETED | 739 | 117 |
| NOT COMPLETED | 290 | 43 |
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 | Lutonix Drug Coated Balloon | Standard Uncoated Angioplasty Balloon | Total |
|---|---|---|---|---|
| Participants analysed | 1029 | 160 | 1189 | |
| Age, Continuous | Years | 68.4 (SD 9.7) | 69.0 (SD 9) | 68.48 (SD 9.5) |
| Sex: Female, Male: Female | Participants | 383 | 53 | 436 |
| Sex: Female, Male: Male | Participants | 646 | 107 | 753 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 39 | 14 | 53 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 988 | 146 | 1134 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 0 | 2 |
| Baseline Rutherford Classification: Rutherford 0 | Participants | 0 | 0 | 0 |
| Baseline Rutherford Classification: Rutherford 1 | Participants | 0 | 0 | 0 |
| Baseline Rutherford Classification: Rutherford 2 | Participants | 354 | 55 | 409 |
| Baseline Rutherford Classification: Rutherford 3 | Participants | 606 | 92 | 698 |
| Baseline Rutherford Classification: Rutherford 4 | Participants | 69 | 13 | 82 |
| Baseline Rutherford Classification: Rutherford 5 | Participants | 0 | 0 | 0 |
| Baseline Rutherford Classification: Rutherford 6 | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure., measured over From index procedure to 60 months Post Index Procedure.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with an unanticipated serious adverse event related to the device or drug, from the index procedure through 60 months after that procedure. It is recorded as a count of participants, rather than as a continuous measurement or a time-to-event estimate. The posted value is 0 in the Lutonix group and 0 in the standard-balloon group.
In general, a safety endpoint of this kind is intended to capture serious harms judged both unexpected and related to the intervention. That definition is narrower than a count of all serious adverse events: the registry also lists broader serious-adverse-event summaries, but those summaries are not equivalent to the primary endpoint. The record does not give a more detailed definition of seriousness, explain how unexpectedness or treatment-relatedness was assessed, or specify how participants with incomplete follow-up were handled.
The endpoint is relevant to long-term safety monitoring because it covers the period through 60 months after the index procedure. A count of zero in each group means no events meeting the posted endpoint definition were recorded in either group. It does not mean that no other serious adverse events occurred, nor does it alone describe every aspect of safety over follow-up.
7. Results Posted in the Registry
- Lutonix Drug Coated Balloon: 0.0% (0/1029) versus 0.0% (0/160) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0); unadjusted two-proportion z-test p = n/a.
Risk difference: Lutonix Drug Coated Balloon
95% CI: 0.0 to 0.0 percentage points
Recalculated from the posted summary statistics
8. Secondary Efficacy Endpoints
The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.
| Secondary outcome | Type | Effect measure | Estimate (95% CI) | Planning size, 80% power |
|---|---|---|---|---|
| Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure | Binary Endpoint | Risk difference | -0.1 pts (-1.4 to 1.3) | 374,269 per arm |
Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure
- Endpoint type: Binary: the number of participants with the event, compared as proportions.
- Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
- Result:
- Lutonix Drug Coated Balloon: 99.3% (1002/1009) versus 99.4% (155/156) on control; risk difference -0.1 percentage points (95% CI -1.4 to 1.3), risk ratio 1.00 (0.99–1.01); unadjusted two-proportion z-test p = 0.941.
- Interpretation:
- The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lutonix Drug Coated Balloon and the control. The interval gives the range of effects that remain compatible with the data.
The registry identifies secondary outcomes covering short- and longer-term safety, patency, revascularization, acute device success, technical and procedural success, and changes in Rutherford classification. The listed follow-up points include 30 days and 6, 12, 24, 36, 48, and 60 months, depending on the outcome. These measures address different aspects of performance and should not be treated as interchangeable with the primary safety endpoint.
The available secondary comparison is for freedom from death, index-limb amputation, and target vessel revascularization at 30 days. Its posted risk difference is -0.001, with a confidence interval from -0.014 to 0.013 and an unadjusted p-value of 0.941. The confidence interval includes zero. Results for the other listed secondary outcomes are not reported in the registry record in the available outcome details, so an overall pattern across those outcomes cannot be established from this record.
The primary endpoint and the 30-day secondary outcome differ in both definition and follow-up period. The primary endpoint counts unanticipated device- or drug-related serious adverse events through 60 months; the secondary outcome combines freedom from specified events at 30 days. Their estimates cannot be combined into a single safety conclusion. The primary result does not establish the direction or size of effects on patency, revascularization, or functional classification.
In general, multiple secondary comparisons create more opportunities for apparently notable results to arise by chance, especially when no adjustment is made. The registry record does not report a multiplicity strategy for the secondary outcomes. The 30-day comparison is explicitly unadjusted, so it carries less confirmatory weight than a prespecified primary analysis with a documented plan. No secondary finding should be isolated from its endpoint definition, follow-up period, precision, and missing-data context.
Secondary outcomes registered for this trial, for reference (only those above were recalculated):
- Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure
- Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure
- Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure
- Number of Acute Device Success at Time of Index Procedure
- Number of Participants With Technical and Procedural Success
- Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure
- Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure
- Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline
9. Statistical Interpretation
The registry record reports 0 participants with an unanticipated device- or drug-related serious adverse event through 60 months in the Lutonix group and 0 in the standard uncoated angioplasty balloon group. The posted risk difference is 0.0, with a confidence interval from 0.0 to 0.0. The reported values therefore show no observed difference for this specific recorded endpoint.
This endpoint is defined narrowly. It concerns events that were serious, unanticipated, and considered related to the device or drug. The registry also reports broader safety counts, and those counts are not interchangeable with the primary endpoint. A reader should not interpret the two zero counts as evidence that no serious adverse events or deaths occurred during the study.
The arm denominators are 1029 and 160. The difference in group sizes is important context when reading counts, because raw counts depend in part on how many participants are represented. The record does not give enough detail to assess follow-up completeness, outcome adjudication, or the handling of participants whose status may not have been known through the full follow-up period. The posted primary result should therefore be understood as the recorded comparison, not as a complete account of all possible events or missing outcome information.
The primary result is descriptive for this endpoint. No primary p-value or inferential analysis is reported in the registry record. The zero estimate and zero-width confidence interval do not establish that the underlying risks are identical. When no qualifying events are recorded in either group, the observed difference is necessarily zero; that pattern provides little information about how often such rare events might occur outside the observed data. The confidence interval’s stated limits also do not convey uncertainty in a way that can be assessed without knowing the calculation method and its assumptions.
The registry’s listed objective refers to long-term performance, but the primary endpoint reported in this record is a safety count. It should not be taken as a summary of treatment effectiveness. Secondary outcomes include patency, revascularization, procedural success, and Rutherford classification, but the primary safety result does not answer those questions. Interpretation of those outcomes depends on their own definitions, available results, and analyses.
10. Statistical Methods Explained
The posted primary endpoint is binary at the participant level: a participant either met the endpoint definition or did not. The registry reports the number meeting the definition in each group, with the arm denominators. General statistical interpretation of a binary outcome often uses the event proportion in each group and a contrast between those proportions. The registry reports a risk difference of 0.0 for the primary endpoint. Because both event counts are zero, the recorded proportions are also zero, but the record does not report a primary p-value or a separate inferential analysis.
What does a risk difference describe?
In general, a risk difference expresses the difference between the event proportions in two groups. It is an absolute contrast, not a relative contrast. A value of 0.0 means that the observed event proportions are equal for the comparison as posted. That describes the observed data; it does not by itself show that the underlying event probabilities are equal. The record does not state a confidence level or calculation method for the primary confidence interval, so those details cannot be evaluated from the registry record.
How should a confidence interval be read?
In general, a confidence interval describes uncertainty around an estimate under a specified statistical procedure and its assumptions. It is not a range of individual participant outcomes, and it does not guarantee that the true value lies within its limits. The primary interval is reported as 0.0 to 0.0. With no qualifying events recorded in either group, this interval should not be read as proof of no possible difference in the underlying risks. The registry record does not explain how the interval was produced or how zero-event data were handled.
What does the secondary comparison add?
The posted 30-day secondary comparison concerns freedom from death, index-limb amputation, and target vessel revascularization. Its risk difference is -0.001, with a confidence interval from -0.014 to 0.013 and an unadjusted p-value of 0.941. In general, a p-value measures how compatible the observed data are with a specified null model under the test assumptions; it is not the probability that the null hypothesis is true. The confidence interval includes zero, so the posted estimate is compatible with no difference as well as with values on either side of zero. No adjustment for multiple comparisons is reported for this result.
Unadjusted re-calculations from posted summary statistics are not the same as a sponsor’s prespecified analysis. In this record, discrepancy is not flagged. The registry does not report an analysis plan or a formal analysis result for the secondary comparison, so the posted estimate and unadjusted p-value should be read as summary statistics rather than as a complete account of the intended analysis.
How should planning illustrations be understood?
General sample-size calculations illustrate the amount of information that might be needed under specified assumptions; they do not describe the study’s observed power. The planning illustration for the 30-day comparison assumes a two-sided significance level of 0.05, equal allocation, and a normal approximation. It gives participants per arm for 80% power and participants per arm for 90% power at 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. These are planning scenarios, not observed enrollment targets or evidence about the study’s design. The sample-size justification for the trial is not reported in the registry record.
11. Confidence Intervals and Precision
The primary estimate is a risk difference of 0.0, with a confidence interval from 0.0 to 0.0. The event count is 0 in each group. Those posted values indicate no observed contrast for the narrowly defined primary endpoint. They should not be interpreted as demonstrating that the underlying risks are exactly equal. The registry record does not report the interval’s confidence level, calculation method, or treatment of zero-event data, which limits assessment of its precision.
The arm denominators are 1029 for the Lutonix group and 160 for the standard-balloon group. Unequal group sizes affect how much information each group contributes, particularly for uncommon outcomes. The registry record does not report the number of participants with complete follow-up for this endpoint, whether every participant was assessed through 60 months, or how any missing follow-up was handled. Those omissions matter when judging how precisely the endpoint was measured.
For the posted 30-day secondary comparison, the risk difference is -0.001 and the confidence interval runs from -0.014 to 0.013. The interval includes zero and extends in both directions around it. In general, this means the estimate is not precise enough to rule out a range of differences under the procedure used to construct the interval. The unadjusted p-value is 0.941. The record does not report a multiplicity adjustment or analysis plan for this secondary result.
Precision is distinct from clinical importance. A narrow interval can still include effects that matter, while a wide interval may leave substantial uncertainty. The registry record does not provide a threshold for a clinically meaningful difference. The posted estimates therefore support a description of the recorded results, but not a judgment about whether any possible difference would matter clinically.
12. Multiplicity, Missing Data and Analysis Populations
The registry record lists multiple secondary outcomes and follow-up times, but it does not report a statistical analysis plan describing how those outcomes were prioritized or how multiplicity was handled. The posted 30-day secondary comparison has an unadjusted p-value of 0.941. No adjustment for multiple testing is reported. In general, when many outcomes or comparisons are examined, the chance of observing a seemingly unusual result can increase; an adjustment or a prespecified hierarchy can help control that issue. Without a reported strategy, secondary results should be treated as exploratory rather than as a coordinated set of confirmatory tests.
The record does not report interim analyses, a stopping rule, a missing-data plan, or the analysis populations used for the outcomes. It does not explain whether participants were analyzed according to randomized assignment, according to treatment received, or under another rule. Nor does it describe how incomplete follow-up, withdrawals, or unknown outcome status were handled. These details are important for a long-term endpoint because the recorded count depends on ascertainment over follow-up.
The registry lists the study as randomized, but information about sequence generation, concealment, and implementation is not reported in the registry record. Masking is recorded as none. The record also does not state whether endpoint events were reviewed by an independent committee or how attribution to the device or drug was determined. These absences do not establish that procedures were absent; they mean the details are not reported in the registry record.
The registry record gives enrollment and arm denominators for the primary outcome, but does not explain participant flow or account for any differences among enrollment, treatment, and outcome assessment. A sample-size justification and the trial’s own planned statistical power are not reported in the registry record. The planning illustration based on the observed secondary effect is not evidence of observed power and does not substitute for a documented design calculation.
13. 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 |
|---|---|---|---|
| Lutonix Drug Coated Balloon | 813 | 1029 | 79.0% |
| Standard Uncoated Angioplasty Balloon | 125 | 160 | 78.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Lutonix Drug Coated Balloon | 147 of 1029 |
| Standard Uncoated Angioplasty Balloon | 17 of 160 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Lutonix Drug Coated Balloon | 845 of 1029 |
| Standard Uncoated Angioplasty Balloon | 126 of 160 |
Most frequent serious adverse event terms
| Event term | Organ system | Lutonix Drug Coated Balloon | Standard Uncoated Angioplasty Balloon |
|---|---|---|---|
| Other | General disorders | 163 of 1029 | 21 of 160 |
| Other Cardiovascular | Vascular disorders | 152 of 1029 | 20 of 160 |
| Stenosis | General disorders | 126 of 1029 | 23 of 160 |
| Restenosis | General disorders | 112 of 1029 | 22 of 160 |
| Other Skeletal, spine and muscular system | Musculoskeletal and connective tissue disorders | 89 of 1029 | 12 of 160 |
| Myocardial infarction | Vascular disorders | 69 of 1029 | 17 of 160 |
| Restenosis | General disorders | 65 of 1029 | 18 of 160 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 75 of 1029 | 7 of 160 |
| Other Gastrointestinal | Gastrointestinal disorders | 68 of 1029 | 11 of 160 |
| Angina, stable | Vascular disorders | 65 of 1029 | 8 of 160 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Lutonix Drug Coated Balloon | Standard Uncoated Angioplasty Balloon |
|---|---|---|---|
| Other | General disorders | 399 of 1029 | 67 of 160 |
| Other skeletal, spine and muscular system | Musculoskeletal and connective tissue disorders | 272 of 1029 | 35 of 160 |
| Other Cardiovascular | Cardiac disorders | 110 of 1029 | 23 of 160 |
| Other Gastrointestinal | Gastrointestinal disorders | 118 of 1029 | 11 of 160 |
| Back pain | Musculoskeletal and connective tissue disorders | 112 of 1029 | 8 of 160 |
| Other respiratory | Respiratory, thoracic and mediastinal disorders | 88 of 1029 | 18 of 160 |
| Other Neurological / nervous system | Nervous system disorders | 92 of 1029 | 13 of 160 |
| Claudication | Musculoskeletal and connective tissue disorders | 79 of 1029 | 17 of 160 |
| Local infection | Infections and infestations | 72 of 1029 | 12 of 160 |
| Urinary infection | Renal and urinary disorders | 72 of 1029 | 9 of 160 |
Serious events with the highest arm-level rate: other (15.8%), other cardiovascular (14.8%), stenosis (14.4%), restenosis (13.8%), myocardial infarction (10.6%).
The primary safety endpoint reports 0 participants with an unanticipated device- or drug-related serious adverse event in each group through 60 months. This is a narrowly defined outcome. The broader safety summary separately lists serious adverse events affecting 813 participants in the Lutonix group and 125 in the standard-balloon group. It also lists other adverse events affecting 845 and 126 participants, respectively, and deaths numbering 147 and 17. These broader counts should not be confused with the primary endpoint.
The group denominators differ, and the registry record does not provide a denominator-adjusted analysis for these broader counts or explain their relation to the primary endpoint. It does not report whether adverse-event categories overlap, how events were attributed, or how missing follow-up was addressed. The listed serious-event terms include Other at 15.8%, Other Cardiovascular at 14.8%, Stenosis at 14.4%, Restenosis at 13.8%, Myocardial infarction at 10.6%, and Other Skeletal, spine and muscular system at 8.6%. The record does not specify the basis for these term percentages. They describe posted event categories and do not by themselves establish comparative risk or causation.
14. What the Result Does, and Does Not, Mean
The primary result establishes what was recorded for the endpoint definition in the registry: 0 qualifying participants in the Lutonix group and 0 in the standard-balloon group through 60 months. The posted risk difference is 0.0. This is a description of the observed endpoint counts, not proof that the underlying risks are identical or that no relevant safety events occurred.
The result does not summarize all serious adverse events, deaths, or other outcomes. The registry reports broader adverse-event counts, and those are distinct from events that were both unexpected and considered device- or drug-related. The endpoint also cannot answer whether one treatment improves patency, reduces revascularization, or changes functional status. Those questions require results for their own outcome definitions and follow-up periods.
The posted 30-day secondary comparison has a risk difference of -0.001, a confidence interval from -0.014 to 0.013, and an unadjusted p-value of 0.941. It concerns freedom from a different set of specified events and should not be treated as confirmation of the primary safety result. Additional outcomes are listed, but their detailed results are not reported in the registry record.
In general, a zero-event observation is compatible with uncertainty about rare events, particularly when follow-up completeness and analysis methods are not described. The registry record does not give enough information to determine the extent of missing outcome data, the method used for the primary interval, or the statistical plan. The estimate therefore supports a limited statement about the posted counts, not a broad conclusion about comparative safety or overall performance.
Clinical importance cannot be inferred from the point estimate alone. No threshold for a meaningful difference is reported in the registry record. The available information is best read as a record-based description of a particular endpoint and comparison, with important methodological details unreported.
15. Why This Trial Matters Statistically
This study is statistically interesting because its primary outcome is a long-term, specifically defined safety count, while the registry also lists outcomes addressing patency, revascularization, procedural success, and functional classification. The distinction illustrates why an endpoint’s definition matters: a zero count for unexpected device- or drug-related serious adverse events is not a zero count for all serious adverse events, and it does not stand in for other measures of device performance.
The primary comparison also highlights the limits of interpreting zero-event results. Both groups have a posted event count of 0, and the risk difference and interval are reported as 0.0. Those values summarize the observed comparison, but do not establish equality of the underlying risks. The record’s lack of detail on interval construction and long-term follow-up completeness makes it difficult to assess how much uncertainty the primary estimate captures.
The randomized, parallel, unmasked design labels and the unequal arm denominators provide context, but the registry does not report the procedures behind randomization or the analysis populations. These details affect how readers assess the credibility and precision of an estimate. Their absence is not proof of flawed methods; it limits what can be evaluated from the registry record.
The secondary outcomes also demonstrate the importance of multiplicity. Several outcomes and follow-up times are listed, while a multiplicity strategy is not reported. The available unadjusted secondary comparison should therefore be interpreted cautiously, and results for the other listed outcomes cannot be inferred from it. Overall, the record is a useful case in separating recorded event counts, comparative estimates, and broader claims about safety or performance.
16. 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.
Several limitations are specific to the information reported for this registry. The primary endpoint concerns unanticipated device- or drug-related serious adverse events, but the record does not provide operational definitions or describe how seriousness, unexpectedness, and relatedness were assessed. It also does not state whether event adjudication was independent. This limits evaluation of how consistently the endpoint may have been classified.
The primary follow-up extends through 60 months, yet the registry record does not report completion rates, loss to follow-up, the number assessed at each follow-up point, or a missing-data approach. It is therefore not possible to determine from the posted information how completely the primary outcome was observed. The primary confidence interval is reported as 0.0 to 0.0, but its calculation method and confidence level are not reported.
The arm denominators are unequal, and the record does not provide participant-flow details that explain how those denominators relate to enrollment and treatment assignment. It also does not report the randomization procedure, concealment, or analysis population. Masking is listed as none, but further information about outcome assessment is not reported.
The registry lists a range of secondary outcomes, but detailed results are not reported in the available outcome details beyond the 30-day comparison. A multiplicity plan, a prespecified statistical analysis plan, interim-analysis information, and a sample-size justification are not reported in the registry record. The planning illustration based on an observed secondary effect does not resolve those gaps. These limitations restrict assessment of the study’s full long-term comparative evidence and should be kept distinct from the posted primary count itself.
17. Related Tutorials
18. Related Statistical Calculators
19. Sources
- ClinicalTrials.gov: LEVANT 2 Safety Registry — NCT01790243.
- Registry record last updated 2020-06-05; status last verified 2020-05.
- Results first posted 2020-06-05.
- 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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20. Record Summary
The LEVANT 2 Safety Registry is recorded as a completed, prospective, multicenter study with randomized allocation, no masking, and a parallel model. Its recorded enrollment is 1189. The primary endpoint counts participants with unanticipated device- or drug-related serious adverse events from the index procedure through 60 months.
The posted primary count is 0 in the Lutonix Drug Coated Balloon group and 0 in the Standard Uncoated Angioplasty Balloon group. The reported risk difference is 0.0, with a confidence interval from 0.0 to 0.0. The registry also posts a 30-day secondary comparison for freedom from specified events, with a risk difference of -0.001, a confidence interval from -0.014 to 0.013, and an unadjusted p-value of 0.941.
Although additional secondary outcomes are listed, their detailed results are not reported in the registry record. Important details about analysis methods, missing data, endpoint assessment, and multiplicity are also not reported.