A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION) (NCT01106391), a na na study. The primary outcome is Rate of Technical Success Through the One Month Follow up..

2. Clinical Question

This is a descriptive question about a device-treated group, not a randomized estimate of how outcomes differ between treatments. The record identifies aneurysm enlargement, stent-graft migration, major adverse events, endoleaks, fractures, thrombosis, explant and patency among its secondary outcome topics, with several assessed annually through 5 years post-procedure. It also lists some device outcomes at 30 days. However, the registry record does not report the primary technical-success result, its denominator, or an uncertainty interval. It therefore does not allow a reader to judge the observed frequency or precision of technical success from the record alone.

3. Trial Design

This is a multicenter, prospective, open-label, non-randomized study with a single group. The registry lists the intervention as the Cordis AAA stent graft system “INCRAFT TM,” and the condition as abdominal aortic aneurysms. The study title identifies INNOVATION. The status is completed; the registry lists the start as 2010-03 and primary completion as 2011-08. The registry lists enrollment as 60, while the brief description says the study would enroll up to 60 subjects at up to 7 sites in Germany and Italy.

In a prospective study, participants are followed forward from the intervention to assess outcomes. General explanation: without random allocation to distinct groups, the study can describe what happened in the enrolled group but does not provide the protection against confounding that random assignment can offer in a controlled comparison. Here there is no separate control arm, and the record explicitly cautions that the arms are not a like-for-like control comparison. The allocation field is listed as NA.

The study is open label, with masking listed as none. General explanation: lack of masking can matter when outcomes depend on assessments or reporting, because knowledge of treatment may influence some observations. The record does not describe which people knew the intervention or how endpoint assessments were conducted. Phase is listed as NA.

The registry describes technical success through one month as the primary outcome. Secondary outcomes cover device performance and clinical events, including aneurysm enlargement and major adverse events, with multiple outcomes extending annually through 5 years post-procedure. A full schedule of assessments, detailed eligibility criteria, methods for follow-up, and the statistical analysis plan are not reported in the registry record. The posted information therefore supports a description of the design and intended questions, but not a detailed reconstruction of how every outcome was collected or analyzed.

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: Of the 78 subjects consented and assessed for eligibility, 18 subjects did not meet all study entrance criteria and were considered screen failure.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All enrolled subjects

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 Rate of Technical Success Through the One Month Follow up., measured over From procedure to one month follow up.

The primary endpoint is the rate of technical success through the one-month follow-up. It is defined at the participant level: successful deployment of the stent-graft to the desired location, with no Types I, III or IV endoleaks at the conclusion of the procedure and through one month. The stated timeframe runs from the procedure to the one-month follow-up, and the analysis population is described as all enrolled subjects.

This endpoint combines a procedural criterion—deployment at the intended location—with the absence of specified endoleak types across the stated period. General explanation: a composite definition can capture more than one aspect of procedural performance in a single outcome, but its interpretation depends on each component being clearly assessed and reported. The registry supplies a definition, but it does not report the number of participants meeting it, the number assessed, or the endpoint estimate.

Technical success is used to summarize whether the intended deployment and specified early procedural conditions were achieved. It is not, by itself, a complete account of longer-term device performance or patient outcomes. The registry separately lists follow-up outcomes such as aneurysm enlargement, migration, endoleaks, fractures, thrombosis, explant, patency and major adverse events. The primary endpoint result and any confidence interval are not reported in the registry record, so the frequency and precision of technical success cannot be evaluated from the posted record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a binary primary outcome measured as a count of participants: whether each enrolled subject met the technical-success definition through one month. General explanation: a binary outcome classifies each participant into one of two categories, such as meeting or not meeting a defined criterion. A participant count can be summarized as a proportion when the number assessed is also known. The registry record does not report the number meeting the endpoint, the number with an observed endpoint assessment, or an estimated proportion.

What would a confidence interval add?

General explanation: a confidence interval expresses the uncertainty around an estimate, such as a proportion. It helps distinguish a result estimated with relatively high precision from one that remains compatible with a wider range of values. It does not guarantee that the true value lies within that particular interval, and it does not address bias caused by study design or data collection. No confidence interval for technical success is reported in the registry record, so precision cannot be judged from the posted primary-outcome information.

What does the single-group design allow?

The study is listed as non-randomized and single-group, with no separate control arm. General explanation: a single-group outcome is descriptive of the participants observed under that study’s conditions. It does not directly estimate a treatment contrast against a concurrent control. Without randomization and a comparator, other characteristics of the participants, their care, or how outcomes were assessed may contribute to observed outcomes. The registry record does not report an adjusted comparison or a plan for controlling confounding.

What do the planning assumptions mean?

The sample-size planning setup is described as an illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not a description of the actual single-group trial design. General explanation: a planning calculation estimates the sample size that would be needed under specified assumptions; it is not evidence that a study had that size, and it is not observed power. The registry record does not report that these assumptions were the sponsor’s original design justification. The sample-size justification is not reported in the registry record.

The planning setup refers to two arms despite the study being described as single-group. It should therefore be understood as a hypothetical planning illustration, not a reconstruction of the trial’s allocation. The record also states that time-to-event planning illustrations, if used, give a total number of events, while other illustrations give participants per arm. The primary outcome described for this study is a participant count, not a time-to-event endpoint. No numerical planning outputs are included in the registry entries for interpretation in this explanation.

What does over-dispersion mean?

General explanation: over-dispersion occurs when the observed variability in data is greater than a statistical model assumes. If a model ignores over-dispersion, standard errors can be too small and confidence intervals or tests can appear more precise than the data warrant. This concept is relevant to some count-data models, but the registry record does not identify a count-data model, report dispersion estimates, or describe an over-dispersion assessment for this study. The primary endpoint is described as a count of participants meeting a binary criterion, and no model or variance method is specified.

Which analyses were used?

The registry indicates two analyses, but the methods and purposes of those analyses are not reported in the registry record. The statistical analysis plan, any covariate adjustment, treatment of repeated measurements, confidence-interval method, and approach to incomplete observations are also not reported in the registry record. The record does not state whether interim analyses were conducted. Those details should not be inferred from the endpoint definition or from the study’s prospective design.

The listed secondary outcomes span different types of measures and timeframes. General explanation: outcomes measured repeatedly over follow-up may require methods that account for timing and the fact that observations from the same participant are related. A time-to-event analysis may also need to address participants who do not experience the event during observation. The registry lists annual outcomes through 5 years post-procedure and some outcomes at 30 days, but does not specify the analysis methods, censoring rules, or handling of incomplete follow-up.

Because the primary result and analysis details are absent, statistical interpretation is limited to the study structure, the outcome definition, and the posted adverse-event figures. A result’s statistical uncertainty, robustness to assumptions, and relationship to other outcomes cannot be evaluated without the corresponding estimates and methods.

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("The INCRAFT™ AAA Stent-graft System")
n      <- c(60)
events <- c(54)
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  The INCRAFT™ AAA Stent-graft System  60  54  90.0  79.5  96.2  79.9  95.3  79.8  95.3

11. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple outcome measures. In addition to technical success through one month, secondary topics include aneurysm enlargement, stent-graft migration, major adverse events, endoleaks, fractures, thrombosis, explant and patency. Several are listed for annual assessment through 5 years post-procedure; some device outcomes are also listed at 30 days. The record does not describe a hierarchy among these outcomes or identify which secondary outcomes, if any, were intended to support confirmatory claims.

General explanation: when many outcomes or repeated analyses are examined, the chance of at least one apparently unusual result can increase. Statistical methods can address this through prespecified outcome hierarchies or adjustments, but those choices depend on the analysis plan. Multiplicity handling is not reported in the registry record. The record indicates two analyses but does not identify their content or whether they involved separate outcomes, time points, or populations.

Missing-data handling is also not reported in the registry record. The primary population is described as all enrolled subjects, but the record does not state how participants without a one-month assessment were handled, whether any endpoint values were missing, or what denominator was used for an endpoint estimate. Follow-up completeness for the secondary outcomes is not reported. General explanation: incomplete follow-up can affect an estimate if participants with missing observations differ from those observed, so the number assessed and the missing-data approach help readers interpret results.

The analysis populations beyond “all enrolled subjects” are not reported in the registry record. There is no description of exclusions, protocol deviations, or alternative analysis sets. As a result, readers cannot determine whether the listed population definition was applied consistently across outcomes or how incomplete observations affected the analyses.

12. 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: hematoma / bleeding puncture site - major (3.3%), pleural effusion (1.7%), strong lymphatic wound secretions without infection (1.7%), claudication (1.7%), dissection (1.7%).

The posted adverse-event figures list 8 participants affected by serious adverse events among 60 at risk, and 44 participants affected by other adverse events among 60 at risk. These are participant-level affected counts as presented in the record. They should not be read as counts of individual event episodes: one participant may have experienced more than one event, and the record does not report event totals or whether the serious and other affected groups overlap.

The serious adverse-event terms listed include hematoma / bleeding puncture site - major at 3.3%, pleural effusion at 1.7%, strong lymphatic wound secretions without infection at 1.7%, claudication at 1.7%, dissection at 1.7%, and lymphocele right groin postoperatively at 1.7%. These entries describe the terms and percentages posted in the record. They do not, on their own, establish that the device caused an event or provide a complete account of all safety outcomes.

Deaths are not reported in the registry record. The record does not explain event ascertainment, severity grading beyond the serious-event grouping, timing, duration of observation, or whether events were judged related to the device or procedure. General explanation: adverse-event counts describe events recorded during a study; causal attribution requires additional evidence and should not be inferred from a count alone. The figures therefore need to be read as the registry’s reported safety data, with those reporting details unavailable.

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

The study addresses whether technical success was achieved after use of the INCRAFT AAA stent-graft system, using a definition tied to deployment and specified endoleak types through one month. The registry record does not report the number or proportion meeting that definition. It therefore does not provide a numerical primary result from which to assess the observed frequency or statistical precision.

The design is a prospective, open-label, non-randomized, single-group investigation. General explanation: outcomes in a single treated group can describe what was observed among participants, but without a comparator they cannot show how outcomes would have differed under another treatment or no treatment. The record does not support a causal estimate of benefit or harm relative to another approach. It also does not provide the information needed to judge how participant selection, follow-up, or outcome assessment may have influenced results.

The listed secondary outcomes indicate that the study planned to examine device performance and clinical events beyond the primary one-month period, including outcomes monitored annually through 5 years post-procedure. Their results are not reported in the registry record. The listing of an outcome is not evidence that a particular event occurred or that a particular level of device performance was observed.

The adverse-event data include affected-participant counts and selected serious-event terms with percentages. These are relevant descriptions of the posted safety record, but without detail on timing, event totals, causality assessment, or complete follow-up they cannot establish causal relationships or provide a full safety profile. Deaths are not reported in the registry record.

In general, an estimate should be interpreted together with its uncertainty, the population analyzed, and the methods used. Here, the primary estimate, uncertainty interval, analysis plan, and missing-data approach are not reported in the registry record. Accordingly, the record supports a description of the study’s design, intended endpoints, and posted adverse-event counts, but not a conclusion about the magnitude or precision of the primary outcome or a comparative treatment effect.

14. Why This Trial Matters Statistically

Statistically, the record is a useful example of the distinction between a study question and a reported result. It defines a primary technical-success endpoint and identifies its timeframe and population, but does not report the endpoint estimate or its uncertainty. A clear endpoint definition is necessary for interpretation, yet it is not a substitute for the observed data and analysis needed to quantify the result.

The single-group, non-randomized design also makes the scope of inference important. A descriptive outcome can characterize the participants followed in the study, but it is not a randomized contrast. The registry’s own design description and warning against treating arms as like-for-like controls reinforce that distinction. Statistical methods cannot, by themselves, create a valid control group where the design does not include one.

The study also lists multiple outcomes across different follow-up periods. General explanation: prespecifying the main outcome and clarifying how secondary outcomes will be interpreted helps readers distinguish the central question from exploratory findings and understand the consequences of examining many measures. The registry record does not report a multiplicity plan, analysis details, or the results for the listed secondary outcomes.

Finally, the posted safety counts illustrate why denominators, event definitions, follow-up, and participant-level versus event-level reporting matter. The record gives affected counts and selected terms, but not enough detail to reconstruct event timing, overlap, or causal attribution. These limitations are not merely technical: they determine what readers can responsibly infer from the posted data. The statistical importance of the record lies in making the endpoint and design visible while also showing that key result and analysis details are not reported.

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.

The primary limitation for interpretation is that the registry record does not report the technical-success result, its denominator, or a confidence interval. Although the endpoint is defined and the outcome population is described as all enrolled subjects, readers cannot determine the observed frequency or its precision. The record also does not report the number of participants assessed at one month.

The single-group, non-randomized design has no concurrent comparator. This limits interpretation to description of the study group and does not support a randomized comparison. The record does not describe adjustments for potential confounding. Its open-label status and absence of masking may be relevant to outcome assessment, but the specific assessment procedures are not reported in the registry record.

Several additional design and analysis details are not reported in the registry record: eligibility criteria, the statistical analysis plan, sample-size justification, interim analyses, analysis populations beyond all enrolled subjects, missing-data handling, endpoint adjudication, and methods for the secondary outcomes. The record lists multiple outcomes and time points but does not describe how multiplicity was handled or provide their numerical results.

The adverse-event record gives affected counts and selected terms, but does not report deaths, event totals, timing, duration of safety follow-up, overlap among affected participants, or causality assessments. These gaps prevent a fuller interpretation of the posted safety information. The registry status is completed, but that status does not supply the missing endpoint estimates or analytical details.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION) — NCT01106391.
• Registry record last updated 2023-01-12; status last verified 2022-04.
• Results first posted 2013-11-26.
• 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

The registry describes NCT01106391, titled “A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION).” It is a completed, prospective, open-label, non-randomized, single-group device study in abdominal aortic aneurysms. The listed intervention is the Cordis AAA stent graft system “INCRAFT TM.” The registry lists enrollment as 60; its brief description states that the study would enroll up to 60 subjects at up to 7 sites in Germany and Italy. The listed start is 2010-03 and primary completion is 2011-08.

The primary outcome is technical success from the procedure through one month, defined by deployment at the desired location without Types I, III or IV endoleaks at the conclusion of the procedure and through follow-up. The primary result and its statistical precision are not reported in the registry record. Secondary outcomes include longer-term device and clinical measures. The adverse-event record reports 8 participants affected by serious adverse events and 44 affected by other adverse events, among 60 at risk in each category. Further analysis, missing-data, and safety-ascertainment details are not reported in the registry record.