Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial (NCT01070069), a randomized na study. The primary outcome is Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC)..

2. Clinical Question

The trial’s stated purpose was to determine the safety and effectiveness of PEVAR. It was a randomized comparison of device-based approaches, with the primary endpoint defined as a composite assessed at 30 days by an independent clinical events committee. The primary endpoint analysis cohort excluded participants in the Prostar XL Roll-in and ProGlide Roll-in groups.

The registry record does not include the primary endpoint counts for the comparison groups. It therefore does not establish from the posted primary outcome data how many participants met the composite definition in each group, nor how precisely any difference between groups was estimated. The adverse-event counts are reported separately and describe participants with serious and non-serious adverse events across listed groups; they do not substitute for the primary endpoint result.

Several details that would sharpen the clinical interpretation, including eligibility criteria, baseline characteristics, and the rationale for selecting the composite endpoint, are not reported in the registry record. The question can therefore be described in terms of the enrolled condition, assigned procedures, comparator, and endpoint, but the available record does not permit a full assessment of how representative the participants were or how endpoint components contributed to any treatment-success result.

3. Trial Design

The PEVAR trial is identified as a prospective, multicenter, randomized controlled trial with a parallel-group model. The registry lists no masking. Its title describes a comparison of a bilateral percutaneous approach with a standard approach using the IntuiTrak endovascular AAA delivery system and a suture-mediated closure system. The listed study condition is abdominal aortic aneurysm, and the listed sponsor is Endologix.

The record lists enrollment of 192 and gives the trial status as completed. The recorded start date is 2010-04-13, and the primary completion date is 2012-03-09. Phase is listed as not applicable. The intervention groups include standard EVAR using IntuiTrak, PEVAR with ProGlide closure, and PEVAR with Prostar XL closure. The standard approach is described as using standard vascular exposure for access; the percutaneous approaches are described as facilitated by their respective closure devices.

Two additional groups are identified as Prostar XL Roll-in and ProGlide Roll-in. The registry explicitly states that these roll-in groups were not part of the primary endpoint analysis cohort. The record does not explain the allocation process, concealment procedures, the size of each randomized group, or the distinction between the roll-in groups and the other intervention groups beyond their names and exclusion from the primary endpoint cohort.

Randomization can support a fair comparison by reducing systematic differences between assigned groups, but the registry record alone does not establish whether that protection was maintained in practice. No masking is listed, so outcome assessment was not described as masked in the registry. The record does identify an independent clinical events committee for primary endpoint determination, but further details about its procedures are not reported in the registry record.

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: 151 Randomized patients and 41 Roll-in patients were enrolled in the study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: PEVAR (Prostar XL Roll-in) and PEVAR (ProGlide Roll-in) were not part of the primary endpoint analysis cohort and hence not included in this section.

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.

6. Primary Endpoint

The registry lists the primary outcome as Treatment Success as Defined as the Composite of Procedural Technical Success, Absence of Vascular Complications, and Absence of Major Adverse Events as Determined by the Independent Clinical Events Committee (CEC)., measured over 30 days.

The primary endpoint is 30-day treatment success, recorded as the number of participants who meet a composite definition. Success requires procedural technical success, absence of vascular complications, and absence of major adverse events. The registry description says that the endpoint was determined by an independent physician adjudicator, and the title identifies an independent clinical events committee.

A composite endpoint combines multiple outcomes into one criterion. This can represent several aspects of procedural performance and safety in a single result. It also means that a participant is counted according to the combined rule rather than through a single event alone. Interpretation depends on the definitions of each component, how they are assessed, and whether the components have similar clinical importance. Detailed component definitions and component-specific primary results are not reported in the registry record.

The endpoint is useful for framing a comparison of technical success and complications after the procedures, but the overall composite cannot reveal which component drove a result. The record does not report primary endpoint counts or an effect estimate, so the posted results do not permit evaluation of the frequency of treatment success or the precision of a comparison. The roll-in groups were excluded from the primary endpoint analysis cohort, as stated in the registry.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary endpoint count?

The primary endpoint is a binary participant-level outcome: each participant either meets the treatment-success definition or does not. That definition combines procedural technical success with the absence of vascular complications and major adverse events at 30 days. The registry records the endpoint as a count of participants, but it does not post the group counts or a comparison estimate. Thus, the outcome type and timeframe are known, while the primary numerical result is not reported in the registry record.

For a binary endpoint, an analysis commonly compares the proportion of participants with the event across groups. That general approach requires both the number with the event and the relevant number assessed in each group. A confidence interval describes the uncertainty around an estimated effect; it is not a guarantee that the true effect lies within its bounds. No primary endpoint confidence interval is reported in this registry record, so no precision claim can be made for the treatment-success comparison.

Why does a composite need careful reading?

A composite endpoint combines distinct events into one outcome according to a prespecified rule. In general, composites can capture multiple dimensions of a procedure without requiring each component to serve as a separate primary outcome. Their interpretation nevertheless depends on component definitions, ascertainment, and clinical relevance. An overall composite result, even if available, would not show whether technical success, vascular complications, or major adverse events accounted for most of the observed outcomes. Component-level primary results are not reported in the registry record.

What do the adverse-event counts represent?

The safety entries state the number of participants with serious adverse events and the number with all non-serious adverse events, alongside the participants at risk in each listed group. These counts are not themselves effect estimates. A comparative analysis would need to account for the study design and provide a measure of uncertainty; no such analysis is reported in the registry record. Counts of participants with events also do not convey the number of events per participant, event timing, duration, or severity beyond the serious versus non-serious classification. Those details are not reported in the registry record.

Over-dispersion is a general concern when event counts vary more than a statistical model expects; it can make uncertainty estimates too small if the model assumes less variation than the data contain. This consideration is relevant to some count outcomes, but the posted safety summaries are participant counts and do not include the event-level information or analysis details needed to assess over-dispersion. The registry does not report the statistical methods used for the safety summaries.

What can be said about planning illustrations?

Any sample-size figures accompanying an analysis are planning illustrations based on an observed effect, not the trial’s original design calculation. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. Such figures describe hypothetical planning under those assumptions. They are not observed power and do not demonstrate that the completed trial had a particular probability of detecting an effect.

The record does not report the trial’s own sample-size justification, target effect, or assumptions used to plan enrollment. The primary endpoint comparison is not available in the registry results, so no conclusion about its observed effect or a planning illustration based on that effect can be drawn from the posted primary endpoint data. The planning assumptions should not be mistaken for the trial’s protocol or its actual analysis plan.

What analysis details are missing?

The registry lists randomized allocation and a parallel design, but the allocation sequence method, concealment, handling of protocol deviations, and statistical model are not reported in the registry record. It also does not report whether primary comparisons were unadjusted or adjusted, which covariates might have been considered, or the method for calculating uncertainty. No formal statistical analyses are listed. Without these details and the primary outcome data, the record supports description of the planned endpoint and posted safety counts, not reconstruction of the trial’s inferential analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists nine outcome measures, including the primary treatment-success endpoint and secondary outcomes such as serious adverse events, health-related quality of life measured by SF-36, clinical utility measures, and non-serious adverse events. Some clinical utility outcome labels appear more than once in the registry list. The record does not explain whether these labels represent distinct assessments, different time points, or separate measures.

When a study examines multiple outcomes or multiple comparisons, the chance of obtaining at least one apparently notable result can increase. Statistical plans may address this through a prespecified hierarchy or an adjustment for multiplicity. Whether such procedures were planned or used is not reported in the registry record. No inferential analyses are listed, and the primary endpoint result is absent, so the posted record does not permit assessment of multiplicity handling.

The registry does not report how missing outcome data were handled, whether any participants lacked endpoint assessments, or whether sensitivity analyses were performed. The primary endpoint cohort excludes the Prostar XL Roll-in and ProGlide Roll-in groups, but the record does not describe other analysis populations or explain how participants were handled after randomization. Intention-to-treat, per-protocol, and modified analysis populations are not described in the registry record.

These omissions limit interpretation because the analysis population and missing-data approach can affect what a reported estimate represents. They also prevent assessment of whether outcome availability differed across groups. The record’s stated endpoint cohort exclusion should therefore be kept distinct from assumptions about the broader analysis strategy, which is not reported.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: vascular disorders (21.1%), injury and procedural complications (15.8%), renal and urinary disorders (11.8%), blood and lymph disorder (10.5%), general disorder (9.1%).

The registry reports serious adverse events as participants with an event over participants at risk. The listed entries are 20 of 50 for Standard EVAR (IntuiTrak), 13 of 50 for PEVAR (ProGlide Closure), 19 of 51 for PEVAR (ProstarXL Closure), 9 of 19 for PEVAR (Prostar XL Roll -In), and 6 of 22 for PEVAR (ProGlide Roll -In). The all non-serious adverse-event entries are 42 of 50, 44 of 50, 39 of 51, 14 of 19, and 20 of 22, respectively.

These are descriptive participant counts, not adjusted treatment comparisons. The roll-in groups are listed for safety but are excluded from the primary endpoint cohort. The record does not provide confidence intervals, hypothesis tests, event timing, or a detailed account of how adverse events were collected. Death counts are not reported in the registry record.

The listed serious-event terms include Vascular Disorders at 21.1%, Injury and Procedural Complications at 15.8%, Renal and Urinary Disorders at 11.8%, Blood and Lymph Disorder at 10.5%, General Disorder at 9.1%, and GI Disorder at 8.0%. The registry does not give the denominator or arm-specific rates for these categories. The counts and term frequencies describe what was recorded; they do not by themselves establish that a procedure caused an event or that groups differ statistically.

12. What the Result Does, and Does Not, Mean

The registry record establishes that the PEVAR trial was a randomized, parallel-group study intended to evaluate safety and effectiveness, and it defines a 30-day composite treatment-success endpoint. It also posts participant counts for serious and non-serious adverse events across five named groups. These registry entries allow readers to understand the broad comparison and the form of the safety summaries.

The record does not report the primary endpoint results. It therefore cannot answer from the posted data how many participants achieved treatment success or how the groups compared on that endpoint. Without an estimate and its uncertainty, it is not possible to assess the size or precision of a primary treatment-success difference. The absence of that result is not evidence that the groups were the same, nor does it demonstrate that one approach was better.

The adverse-event counts also have limits. They are descriptive and are not accompanied by comparative estimates, confidence intervals, or a reported statistical analysis. The registry’s list of event categories does not identify which arm contributed each percentage. In addition, the roll-in groups are included in the adverse-event entries but excluded from the primary endpoint cohort, so those groups do not represent the primary comparison population.

The trial record does not report enough methodological detail to assess missing data, the full analysis population, multiplicity procedures, or the prespecified statistical plan. General statistical considerations can explain why these details matter, but they cannot fill the gaps in the record. The conclusions that can be drawn are consequently limited to the trial’s stated design, endpoint definition, and posted adverse-event descriptions. No clinical recommendation follows from these registry entries alone.

13. Why This Trial Matters Statistically

This trial is statistically notable because its primary endpoint is a composite intended to combine procedural performance and safety within a defined 30-day timeframe. A composite can be a useful way to represent several dimensions of an intervention, but its meaning depends on the component definitions and on which components account for the result. Since neither the primary counts nor component-specific results are reported, the central inferential question remains unanswered in the registry record.

The study also illustrates why analysis populations need to be explicit. The record identifies roll-in groups and states that they were excluded from the primary endpoint cohort, while adverse-event counts are listed for those groups. Keeping the primary endpoint cohort distinct from the safety listings is necessary to avoid treating all reported groups as though they contributed to the same analysis.

Randomized allocation is an important design feature for comparative inference, but interpretation still depends on complete outcome reporting, suitable analysis methods, and transparent accounting for participants. Here, the registry identifies the broad design but does not report the primary comparison, statistical analysis, missing-data approach, or multiplicity plan. This makes the record a useful example of the difference between a registered question and an assessable result.

Finally, the safety counts show the value and limitations of descriptive reporting. Counts convey the number of participants recorded with events in each group, but without uncertainty estimates and a comparative analysis they do not establish the precision or statistical significance of differences. The trial’s statistical importance is therefore as much about the information absent from the registry entry as about the information it does report.

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 trial record is that the primary endpoint result is not reported. Although the composite definition and timeframe are given, the number of participants meeting the endpoint and any comparison estimate are absent. The record therefore cannot support an assessment of the primary outcome’s magnitude or precision.

Several design and analysis details are also missing. The registry does not report the allocation method, concealment, sample-size justification, analysis model, confidence intervals, missing-data procedures, or multiplicity strategy. Baseline characteristics, eligibility criteria, and detailed component definitions are not reported in the registry record. These omissions prevent a fuller assessment of comparability, representativeness, and analytic robustness.

The posted adverse-event counts are descriptive. No comparative statistical analysis or uncertainty estimates accompany them, and death counts are not reported in the registry record. The serious-event term percentages lack an identified denominator and group breakdown in the record. The safety entries also include roll-in groups that were excluded from the primary endpoint cohort, so the safety and primary endpoint populations should not be conflated.

The record lists nine outcome measures, but repeated clinical utility labels are not explained. The absence of a listed analysis does not reveal whether analyses were conducted outside the registry record; it means only that such analyses are not reported in the registry record. These limits restrict interpretation to the study description and posted counts and do not permit reconstruction of the trial’s full results.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial — NCT01070069.
• Registry record last updated 2022-06-07; status last verified 2022-03.
• Results first posted 2022-06-07.
• 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.

18. Record Summary

The PEVAR trial is listed as a completed, prospective, multicenter, randomized, parallel-group study of endovascular aneurysm repair for abdominal aortic aneurysm. The registry records enrollment of 192, no masking, and phase as not applicable. The recorded start date is 2010-04-13, and the primary completion date is 2012-03-09.

Interventions include standard EVAR using IntuiTrak and PEVAR using ProGlide or Prostar XL closure. The primary endpoint is 30-day treatment success, defined as technical success without vascular complications or major adverse events. The Prostar XL Roll-in and ProGlide Roll-in groups were excluded from the primary endpoint analysis cohort.

The registry posts serious and non-serious adverse-event participant counts for five groups but does not report primary endpoint results, comparative analyses, or confidence intervals. Further details about the statistical plan, missing data, and analysis populations are not reported in the registry record.