A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION) (NCT01664078), a na na study. The primary outcome is Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate.

2. Clinical Question

The primary endpoint is a participant count, not a comparison between treatment groups. The composite includes death, stroke, myocardial infarction, new-onset renal failure requiring dialysis, respiratory failure requiring mechanical ventilation, paralysis or paraparesis, bowel ischemia requiring surgical intervention, and procedural blood loss of at least 1,000 cc. The record describes the measure as a number of participants with incidence of MAE based upon a composite MAE rate.

This question concerns the frequency of specified events after the procedure in the enrolled study group. It does not, by itself, establish what would have happened to comparable participants receiving another device or strategy. Because the study has no randomized comparison group, its primary question is descriptive: it concerns the recorded experience of the participants treated with InCraft® in this study, rather than a causal estimate of the difference between treatments.

The registry record states that the study was intended to evaluate safety and effectiveness. However, it does not report the primary endpoint result, an effect estimate, or a confidence interval. The degree to which the observed endpoint count can be estimated precisely therefore cannot be assessed from the primary outcome information in the record.

3. Trial Design

INSPIRATION is a multicenter, open-label, prospective, non-randomized, single-group study of the InCraft® stent graft system in subjects with abdominal aortic aneurysms. The registry lists the condition as abdominal aortic aneurysm and the intervention as endovascular repair using the InCraft device. The study phase is recorded as NA. Allocation is also recorded as NA, and masking is listed as none.

The registry enrollment is 190. The recorded start is 2012-07, primary completion is 2014-10, and study status is completed. Cordis US Corp. is listed as the sponsor. These details describe the registry record; they do not establish how many participants contributed to each particular outcome analysis. The analysis population and outcome-specific denominators are not reported in the registry record, apart from the denominators shown in the adverse-event summary.

A prospective study follows participants forward according to its study procedures. Open-label means that masking is not listed; the record explicitly gives masking as none. In a single-group design, participants receive the named intervention and outcomes are described for that group. There is no concurrent randomized control group in this record against which to estimate a treatment contrast.

The registry lists 13 outcome measures and one analysis. That listing does not specify which statistical methods were used for the primary endpoint or whether the listed analysis corresponds to a particular outcome. The protocol, detailed analysis plan, eligibility criteria, follow-up beyond the stated primary endpoint timeframe, and rules for handling deviations are not reported in the registry record. No sample-size justification for the trial is reported in the registry record. The planning assumptions associated with sample-size illustrations are not evidence that the study was designed or analyzed according to those assumptions.

The registry’s non-randomized, single-group design matters when interpreting the stated aim of evaluating safety and effectiveness. The study can describe events recorded among participants treated with InCraft®, but the design does not provide a randomized, like-for-like control comparison. The record itself cautions that its arms are not a like-for-like control comparison; no separate control arm is described for the primary study question.

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

Reasons for not completing this period:

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 Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate, measured over 30 days post-procedure.

The primary endpoint is the number of participants with incidence of a major adverse event, based on a composite, during the 30 days post-procedure. It is a participant-level binary outcome: a participant is counted if at least one component event occurs within the specified period. The measure is reported as a count of participants, not as a total count of every event. A participant with more than one component event would still be one participant for this endpoint.

The composite includes death, stroke, myocardial infarction, new-onset renal failure requiring dialysis, respiratory failure requiring mechanical ventilation, paralysis or paraparesis, bowel ischemia requiring surgical intervention, and procedural blood loss of at least 1,000 cc. Combining components creates a single summary endpoint for events that the registry groups as major adverse events. As a general statistical principle, a composite can capture whether any qualifying event occurred, but it does not show which component accounts for the endpoint without component-specific results.

The registry record identifies the endpoint and timeframe but does not report the number of participants meeting it. It also does not report component-specific primary endpoint results, an uncertainty interval, or a statistical comparison. The adverse-event summary is a separate listing and should not be treated as the primary endpoint result: the record does not establish that its event categories, definitions, or observation window match the composite endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a participant count represent?

The primary measure is a count of participants who experienced a qualifying event. For this type of binary endpoint, each participant is classified according to whether at least one event in the composite occurred within the specified timeframe. The measure is not the number of separate episodes, and it does not indicate how many components occurred in each participant. If component-level counts are available, they help clarify what contributes to a composite; those primary component results are not reported in the registry record.

General statistical explanation: a count is easiest to interpret alongside the number of participants assessed for the outcome. The count describes the number observed, while a proportion uses that count in relation to the outcome denominator. Neither quantity alone describes precision. Here, the primary endpoint count and its analysis denominator are not reported in the registry record, so neither a primary proportion nor its uncertainty can be stated.

What does a composite endpoint capture?

The endpoint combines several different events under a single major adverse event definition. A participant qualifies if any listed component occurs. This approach can summarize whether a participant experienced at least one event from the set, but the resulting composite can conceal variation among its components. A result driven by one component would have a different clinical interpretation from a result distributed across several components. The registry record does not provide primary endpoint component results, so the relative contribution of each component cannot be assessed.

General statistical explanation: when interpreting a composite, it is useful to inspect the component definitions, their severity, and their individual results, as well as the overall composite. The listed definitions help establish what qualifies here, including events with specified requirements such as dialysis or mechanical ventilation. The registry record does not report additional adjudication procedures or details about how each component was confirmed.

Why does the design affect statistical interpretation?

This is a prospective, open-label, non-randomized, single-group study. A single group can provide a description of outcomes observed after the intervention, but it does not directly estimate a difference against a concurrent randomized control group. Randomization is a design method used to support comparability of groups, on average, for measured and unmeasured factors. Since no randomized comparison is described, a causal contrast between InCraft® and another treatment cannot be obtained from the primary study question.

General statistical explanation: open-label designs can also leave outcome assessment and participant or clinician decisions unmasked. Whether that affects an outcome depends on how the outcome is defined and ascertained. Masking is listed as none; details about outcome adjudication and assessment procedures are not reported in the registry record. This limitation should be distinguished from the endpoint’s explicit definitions, which identify the events included but do not explain the assessment process.

How should uncertainty and planning assumptions be understood?

General statistical explanation: a confidence interval expresses uncertainty around an estimate under a specified statistical model. A narrower interval generally indicates greater precision, whereas a wider interval indicates less precision. It does not remove possible bias from study design, outcome measurement, missing data, or participant selection. No confidence interval for the primary endpoint is reported in the registry record, so its precision cannot be evaluated.

The sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The planned effect is described as a stated fraction of the observed effect. The record does not report the numerical fraction values or sample-size illustration results. General statistical explanation: planning calculations estimate how much information a future study might need under chosen assumptions; they are not results from the current trial. They should not be interpreted as observed power, nor as evidence that this single-group study used a two-arm design.

The illustration distinguishes between participants per arm for non-time-to-event outcomes and total events for time-to-event calculations. The primary endpoint described in the registry is a participant count, not a time-to-event measure. No primary endpoint planning result or trial-specific sample-size justification is reported in the registry record.

What can the analysis listing tell the reader?

The registry lists 13 outcome measures and one analysis. Those entries describe the breadth of registered outcomes and the count of analyses listed, but do not identify the statistical model, testing procedure, adjustment strategy, or analysis population for the primary outcome. General statistical explanation: a method should be interpreted in light of the estimand, outcome definition, follow-up period, and assumptions it uses. Without the analysis details, those assumptions cannot be evaluated for this endpoint.

Because the endpoint is not reported, there is no primary effect estimate to recalculate from posted summary statistics. No recalculated estimate or comparison is available in the registry record. The interpretation therefore rests on the design, endpoint definition, and adverse-event summaries, rather than an inferential primary endpoint result.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("InCraft® - AAA Stent Graft System")
n      <- c(183)
events <- c(20)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  InCraft® - AAA Stent Graft System  183  20  10.9  6.8  16.4  7.2  16.3  7.2  16.3

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures and one analysis. It does not report how the primary endpoint was prioritized relative to the other outcomes beyond identifying it as primary, nor does it describe a multiplicity adjustment, testing hierarchy, or family-wise error strategy. Whether or how multiple outcome analyses were handled is not reported in the registry record. A count of registered outcomes alone does not establish how many statistical tests were performed or how their results were interpreted.

General statistical explanation: evaluating multiple outcomes or repeated tests can increase the chance of at least one apparently unusual result when each test is considered separately. Statistical plans may address this through prespecified priorities or adjustments, but the registry record does not describe such procedures. It would be inappropriate to assume either that an adjustment was used or that none was used in the underlying study.

Missing-data methods are also not reported in the registry record. The record does not state how participants with incomplete follow-up, unavailable endpoint assessments, or withdrawals were handled. The enrollment figure does not establish the number included in the primary endpoint analysis. The primary analysis denominator and missingness by outcome are not reported in the registry record.

The analysis population is not specified. The record does not state whether the primary analysis included all enrolled participants, only participants who received the procedure, or another defined group. It also does not describe any exclusions from analysis or sensitivity analyses. These omissions limit assessment of potential bias from incomplete follow-up or analysis-set selection, but they do not prove that such problems occurred.

For a participant-level composite, transparent reporting would ordinarily identify the number assessed, the number meeting the endpoint, how missing outcome status was treated, and the analysis method. The record identifies the composite and its timeframe but does not report those primary analysis details. No imputation method or sensitivity analysis is reported in the registry record.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: cardiac disorders (8.0%), nervous system disorders (4.8%), vascular disorders (4.8%), general disorders and administration site conditions (3.7%), injury, poisoning and procedural complications2 (3.2%).

The registry’s adverse-event summary lists serious adverse events for 52 among 188 at risk and other adverse events for 93 among 188 at risk. It also lists 45 deaths. These are adverse-event summary entries and should be read separately from the primary endpoint, which is a defined 30-day composite and has no result reported in the registry record. The adverse-event summary does not establish that its categories use the same definitions, observation window, or analysis population as the primary endpoint.

The listed serious event terms include cardiac disorders at 8.0%, nervous system disorders at 4.8%, vascular disorders at 4.8%, general disorders and administration site conditions at 3.7%, injury, poisoning and procedural complications2 at 3.2%, and neoplasms benign, malignant and unspecified (including cysts and polyps) at 3.2%. These are descriptive percentages attached to the listed terms; the registry record does not explain their calculation or provide term-specific denominators.

The 45 deaths are listed separately, without a timeframe in the adverse-event summary. The record does not explain how that figure relates to the 30-day primary composite. It should not be assumed to be a count of participants meeting the primary endpoint. The summary is not a comparison against another treatment group, and it cannot by itself establish attribution or causation.

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

The record establishes that INSPIRATION was a prospective, open-label, non-randomized, single-group study of endovascular abdominal aortic aneurysm repair using InCraft®. It also defines a primary safety endpoint: the number of participants experiencing at least one specified major adverse event during the 30 days post-procedure. Those design and endpoint details allow a reader to understand what the study set out to describe.

The primary result itself is not reported in the registry record. There is no endpoint count, primary analysis denominator, confidence interval, or primary statistical comparison available in the record. Consequently, the primary outcome’s observed frequency and precision cannot be described. The adverse-event figures provide some separate descriptive safety information, but they do not fill in the missing primary endpoint result.

The study design does not include a randomized comparator. Therefore, the record does not estimate how outcomes would differ under another device or treatment strategy, and it cannot isolate the effect of InCraft® from other factors that may influence outcomes. This limitation does not make the recorded study group information meaningless; it defines the type of question the design can answer. It can describe the recorded experience of its participants, but the primary outcome result needed for that description is absent from the record.

Nothing in the record supports a claim that the device does or does not work. A registry description of intended objectives is not an efficacy result. Likewise, an adverse-event summary without a comparator and without details about attribution does not establish whether an event was caused by the device or procedure. Such judgments require information beyond the listed counts and terms.

In practical statistical terms, the record is more informative about study structure and endpoint specification than about the primary outcome. It reports enrollment, timeframe, intervention, design, and selected adverse-event summaries, but it does not report the primary endpoint findings or enough analysis details to assess their robustness. Conclusions should remain within those boundaries.

14. Why This Trial Matters Statistically

This trial illustrates why the design and reporting context matter as much as an endpoint definition. The primary outcome is a clearly specified participant-level composite with a defined 30-day timeframe and listed component events. Yet the registry record does not report the number of participants meeting it. Without that result, a reader cannot quantify the outcome the study identifies as primary, even though the endpoint itself is described.

The single-group, non-randomized design also makes the distinction between description and comparison especially important. A study can record events after an intervention, but a treatment contrast requires an appropriate comparison. The registry record explicitly identifies the arms as not a like-for-like control comparison and gives no randomized comparator for the primary question. This is a design limitation on causal interpretation, not a numerical uncertainty that can be solved by adding a calculation.

The record also demonstrates that safety summaries and primary endpoints are not interchangeable. The adverse-event listing contains counts and selected percentages, while the primary endpoint is a separate composite with its own definition and timeframe. Keeping those summaries distinct prevents a reader from treating a general adverse-event count as if it answered the prespecified primary question.

Finally, registered outcome counts and planning assumptions should not be confused with observed trial findings. Thirteen outcome measures and one analysis are listed, but the analysis methods and missing-data procedures are not reported in the registry record. The sample-size assumptions are illustrations, not evidence of observed power or the trial’s own design. Together, these distinctions show why an interpretable statistical account needs outcome results, denominators, uncertainty, and analysis details as well as a study description.

15. 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 specific to this record constrain interpretation. The primary endpoint result is not reported, despite the endpoint definition and timeframe being stated. The primary analysis denominator, number of participants with complete endpoint information, and component-specific primary results are also not reported in the registry record. This prevents assessment of the endpoint’s observed frequency and precision.

The non-randomized, single-group design does not provide a randomized comparator or a like-for-like control comparison. Accordingly, outcomes cannot be interpreted as a comparative treatment effect from this record. Open-label status is recorded as no masking, while procedures for event adjudication or independent outcome assessment are not reported in the registry record.

The adverse-event summary gives counts among 188 at risk and lists 45 deaths, but its timeframe and relationship to the primary endpoint are not reported in the registry record. The term-specific percentages are listed without term-specific denominators or an explanation of their calculation. The summary therefore cannot be assumed to represent the same population, definitions, or period as the primary endpoint.

The registry lists 13 outcome measures and one analysis but does not describe the statistical methods, missing-data handling, analysis population, multiplicity approach, or sensitivity analyses. The record also does not report a trial-specific sample-size justification. These omissions do not establish that appropriate procedures were or were not used; they limit what can be evaluated from the registry record. The listed planning assumptions should not be treated as the trial’s actual design or analysis.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION) — NCT01664078.
• Registry record last updated 2024-07-03; status last verified 2020-08.
• Results first posted 2020-08-10.
• 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.

19. Record Summary

INSPIRATION (NCT01664078) is recorded as a completed, multicenter, open-label, prospective, non-randomized, single-group study sponsored by Cordis US Corp. The registry enrollment is 190; the recorded start is 2012-07 and primary completion is 2014-10. The intervention is endovascular abdominal aortic aneurysm repair using the InCraft® stent graft system.

The primary endpoint is the number of participants with at least one event in a specified major adverse event composite during the 30 days post-procedure. The registry record does not report the primary endpoint result or its analysis denominator. The separate adverse-event summary lists serious adverse events for 52 among 188 at risk, other adverse events for 93 among 188 at risk, and 45 deaths, alongside selected serious event terms and percentages. The record does not establish that these summaries match the primary endpoint’s definition or timeframe.

Because the study is single-group and non-randomized, it does not provide a randomized treatment comparison. Statistical methods, analysis population, and missing-data procedures are not reported in the registry record.