ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection (NCT02380716), a na phase not stated study. The primary outcome is All Cause Mortality at 30 Days Post-procedure.

2. Clinical Question

Secondary outcomes address technical success, major adverse cardiovascular and cerebrovascular events (MACCE), individual MACCE components, aorta-related mortality, device migration, and endoleak. Several of these are assessed at specified follow-up times, including 30 days, 6 months, and 12 months. These outcomes provide a broader view of procedural and follow-up events, but their results are not included in the registry record. The adverse-event listing does include serious and other adverse events for the treated group; those figures are distinct from a reported result for the primary 30-day mortality endpoint.

3. Trial Design

ARISE (NCT02380716) is a completed, single-group study of the GORE® Ascending Stent Graft for DeBakey Type I/II aortic dissection. The record lists W.L.Gore & Associates as the sponsor, an enrollment of 21, and a study start of 2015-08. The primary completion date is 2021-02-26. Allocation is recorded as NA, masking as none, and the model as single group.

All participants were in the group named GORE® Ascending Stent Graft, whose description is treatment with that device. Because there is no separate comparison arm, the design can describe outcomes among participants in the study but does not provide a randomized comparison of the device with another treatment or with no device. Differences between the observed outcomes and outcomes under an alternative approach cannot be attributed to the device using this design alone.

The primary outcome is all-cause mortality at 30 days post-procedure, measured as a participant count. Listed secondary outcomes include successful dissection treatment, MACCE and its individual components, aorta-related mortality, device migration, and endoleak. Some secondary outcomes have follow-up assessments through 12 months. The record does not report a detailed protocol, eligibility criteria, recruitment procedures, treatment implementation details, or the timing and methods of all outcome assessments.

The trial status is completed, but completion does not itself establish that every planned outcome result or statistical analysis is available in the registry record. No analyses are listed. The record also does not state whether the study had a concurrent or historical comparison for its analyses; none is identified in the posted design. Interpretation should therefore focus on what the record reports about the treated group and distinguish those observations from comparative evidence.

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

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 All Cause Mortality at 30 Days Post-procedure, measured over 30 days post-procedure.

The primary endpoint counts participants who die from any cause within 30 days post-procedure. It is a binary event recorded for each participant—death within the specified period or no such event—and the endpoint is summarized as a count of participants. All-cause mortality does not depend on deciding whether a death was caused by the device or by the underlying condition, which makes the outcome definition broad and clinically direct.

A short-term mortality endpoint is used to describe an important outcome following a procedure. Its interpretation depends on the number of participants assessed, the number with the event, and whether follow-up is complete for the stated period. A count alone does not convey the precision of an estimate or establish whether the observed frequency is higher or lower than it would be under another approach.

The registry record specifies the endpoint and its timeframe, but does not report the primary endpoint result. It therefore does not establish how many participants died within 30 days post-procedure. The adverse-event group separately lists 6 deaths, but the record does not identify those deaths as deaths within the primary endpoint timeframe. They should not be substituted for the missing primary result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record identifies a binary primary outcome: whether a participant died from any cause within 30 days post-procedure. In general, a binary outcome classifies each participant according to whether an event occurred during a defined period. A count of participants with an event is an intuitive summary, while an estimate of event frequency also requires the relevant denominator and a clear account of who was assessed. The registry record gives the endpoint definition but does not report its result.

What a single-group design can estimate

In general, a single-group study describes outcomes among the participants who received the study intervention. Without a comparison group, it does not directly estimate the difference between outcomes under the intervention and outcomes under an alternative. This distinction matters even when an outcome is objectively defined: the outcome count describes what happened in the enrolled group, not what would have happened to those same participants under another treatment.

ARISE is recorded as single group, with allocation NA and masking none. No randomized comparison is identified. The record therefore does not support a treatment-effect estimate based on random allocation between arms. The degree to which the observed group represents other people with the condition, or how its outcomes relate to other treatment settings, also cannot be determined from these design details alone.

What counts and percentages communicate

In general, a count states how many participants experienced an event. A percentage expresses the count relative to a denominator, but a percentage is most interpretable when the denominator, event definition, and observation period are clear. Neither a count nor a percentage by itself describes uncertainty. A confidence interval, when reported, gives a range of values compatible with the data under the method used; wider intervals generally indicate less precision. No confidence interval for the primary endpoint is reported in the registry record.

The serious and other adverse-event entries include denominators of 21 participants at risk and counts of 19 and 9 participants affected, respectively. The record also lists percentages for serious-event terms. These are descriptive quantities, not comparative estimates. The registry entry does not specify whether an individual could contribute to multiple event terms, how repeat events were handled, or whether the term percentages refer to participants, events, or another unit. Those details should not be inferred from the listing alone.

How to read follow-up outcomes

The listed outcomes include assessments at 30 days, 6 months, and 12 months for some event categories, as well as device migration and endoleak assessments through 1 month, 6 months, and 12 months. In general, outcomes at different follow-up times answer different questions because the opportunity to observe an event changes with time. Interpretation also depends on whether participants remained under observation and how events after withdrawal or incomplete follow-up were handled. The record does not report those handling details or results for these secondary outcomes.

For time-to-event analyses, the time until an event and the timing of censoring can be relevant, particularly when participants have different lengths of observation. No such analyses are listed in the registry record. It would therefore be inappropriate to assume that a survival analysis, hazard ratio, or other time-to-event method was used. A count at a specified time and a time-to-event estimate are not interchangeable summaries.

Planning illustrations are not trial results

In general, sample-size planning uses assumptions about the outcome, the effect a study aims to detect, the significance level, the allocation design, and the statistical method. A planning illustration is not a result and does not show the probability that a completed study detected an effect. The record’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They describe an illustration based on a fraction of an observed effect, not the single-group study design recorded for ARISE. No calculated planning values are present in the record, and those assumptions should not be taken as the trial’s own design justification.

General statistical interpretation also distinguishes the significance level used in a planning or testing procedure from the precision of an estimate. A p-value, if reported, would address compatibility between data and a specified statistical model under a null hypothesis; it would not establish the probability that a treatment works. No analyses or p-values are listed for this study. Given the absence of a primary result and a comparator, there is no reported inferential estimate on which to base such a test-based interpretation.

Why analysis details matter

In general, a prespecified analysis plan helps clarify which outcomes are primary, how multiple outcomes are handled, which participants are included, and how missing observations are treated. Those choices affect what an estimate represents and how uncertainty should be assessed. The registry record identifies a primary endpoint and secondary outcomes, but does not report a full statistical analysis plan, analysis populations, missing-data methods, or interim-analysis procedures. These omissions limit the ability to assess whether the reported adverse-event summaries or any unavailable outcome analyses followed prespecified 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("GORE® Ascending Stent Graft")
n      <- c(19)
events <- c(3)
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  GORE® Ascending Stent Graft  19  3  15.8  3.4  39.6  5.5  37.6  5.7  37.9

11. Multiplicity, Missing Data and Analysis Populations

The record names one primary outcome and 7 secondary outcomes. The secondary outcomes cover technical success, MACCE, individual MACCE components, aorta-related mortality, device migration, and endoleak. Considering multiple outcomes can increase the chance that at least one result appears notable by chance when many statistical tests are performed. In general, multiplicity procedures may control that risk, but the appropriate approach depends on the planned questions and testing structure.

No analyses are listed, and the registry record does not report whether multiplicity was addressed, whether a hierarchy of secondary outcomes was planned, or whether any results were exploratory. It also does not report a statistical analysis plan or interim-analysis procedures. No adjustment method should be assumed.

Missing-data handling is not reported in the registry record. In general, missing outcomes can affect an estimate if the participants with observed data differ from those without observed data. Interpretation depends on the amount and pattern of missingness, the reason data are missing, and the analysis method. The record does not state whether follow-up was complete for the primary endpoint or how incomplete assessments were handled.

The analysis populations are not reported in the registry record. It is therefore unclear which participants would have been included in any primary or secondary outcome analysis, or whether analyses used all enrolled participants, treated participants, or another defined set. The enrollment of 21 and the adverse-event denominators do not, by themselves, establish the population used for the primary endpoint. These omissions limit reproducibility and make it difficult to judge the robustness of any outcome interpretation.

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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: cerebrovascular accident (23.8%), aortic valve incompetence (14.3%), atrial fibrilation (14.3%), respiratory failure (14.3%), stent-graft endoleak (14.3%).

The adverse-event entry is for the GORE® Ascending Stent Graft group. It reports 19 participants with a serious adverse event among 21 at risk, 9 with an other adverse event among 21 at risk, and 6 deaths. These are participant counts in the registry listing. The record does not report the timing of the deaths or establish that they occurred within 30 days post-procedure, so they should not be read as the primary endpoint count.

The serious-event terms listed are Cerebrovascular Accident at 23.8%, Aortic Valve Incompetence at 14.3%, Atrial Fibrilation at 14.3%, Respiratory Failure at 14.3%, Stent-Graft Endoleak at 14.3%, and Bacteraemia at 9.5%. These percentages should be interpreted as the registry’s reported term values, not as estimates of comparative risk. The record does not clarify whether participants could have more than one listed event, whether repeat occurrences were counted, or whether each event was considered related to the device or procedure.

In general, adverse-event summaries describe events observed during a specified period; causal attribution and comparison require additional information. The registry record does not report event-level timing, severity definitions beyond the serious/other categories, duration, or attribution. The figures therefore describe the recorded safety experience but do not, on their own, establish why events occurred or how the experience compares with another treatment.

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

The study addresses the feasibility of treating DeBakey Type I/II aortic dissection with the GORE® Ascending Stent Graft. Its single-group design and enrollment of 21 make the record useful for understanding the study’s intended focus and the kinds of outcomes it tracked. The adverse-event entry also gives descriptive counts and serious-event terms for the treated group.

The primary outcome is all-cause mortality at 30 days post-procedure, but its result is not reported in the registry record. The 6 deaths in the adverse-event entry cannot be assumed to match that endpoint because the registry does not state their timing relative to the procedure. Results for the named secondary outcomes are also not reported, and no analyses are listed. Thus, the record does not establish the study’s observed primary endpoint count or its results for technical success, MACCE, migration, endoleak, or aorta-related mortality.

Even a fully reported outcome count from this design would describe the enrolled group rather than show what would have happened under another treatment. Without a comparator, there is no direct estimate of a between-treatment difference. The posted information also does not provide confidence intervals or other measures of precision for the primary endpoint.

In general, a feasibility study can inform whether a treatment approach has been evaluated and can identify practical or outcome questions for further study. The registry record does not report a formal feasibility threshold, a sample-size justification, or conclusions about feasibility. It should not be read as establishing that the device is effective, ineffective, safe, or unsafe. Those claims require results and supporting comparative evidence that are not reported in this entry.

14. Why This Trial Matters Statistically

ARISE is statistically notable as a completed, single-group device study with a clearly named short-term primary outcome and several follow-up outcomes. The design illustrates an important distinction in clinical research: documenting outcomes among treated participants is not the same as estimating a treatment contrast. That distinction remains essential even when an outcome such as all-cause mortality has a direct definition.

The registry lists enrollment of 21 and provides descriptive adverse-event counts and terms. Such information can help readers understand what safety outcomes were recorded in the study group. At the same time, the missing primary endpoint result and the absence of listed analyses demonstrate why a study’s outcome definitions and adverse-event entries cannot substitute for complete outcome reporting. Without the primary count and an uncertainty measure, the precision of the primary estimate cannot be evaluated.

The named secondary outcomes span procedural success, cardiovascular and cerebrovascular events, mortality, device migration, and endoleak. These outcome categories indicate the breadth of questions the study set out to track, but the record does not include their results. Nor does it explain the analysis populations, missing-data handling, or multiplicity approach. Those details matter for judging how fully the evidence answers the stated questions.

In general, studies without a comparator can contribute descriptive evidence, while causal comparisons require a design and analysis that support contrasts between treatment strategies. For this study, the record’s statistical value lies in making the design and outcome framework visible, while also showing important limits in the posted results. Clear separation of design details, observed safety summaries, missing results, and causal claims is necessary for sound interpretation.

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 most immediate limitation is incomplete outcome reporting in the registry record. Although all-cause mortality at 30 days post-procedure is designated as the primary endpoint, its result is not reported. Results for the named secondary outcomes are also absent, and the record lists no analyses. The adverse-event count of 6 deaths does not resolve the primary endpoint gap because its timeframe is not specified.

The single-group design has no separate comparator. It can describe events in the treated group but cannot directly estimate how outcomes compare with another treatment. The absence of masking is recorded, but the record does not provide further details about outcome ascertainment or adjudication. The allocation entry is NA, consistent with the single-group model, and there is no randomized contrast to interpret.

Enrollment was 21, and no sample-size justification is reported in the registry record. The planning assumptions listed for an illustration do not establish the trial’s own design rationale, especially because those assumptions describe equal allocation between two arms while the study is recorded as single group. No planning output is included in the record.

Other limitations are that eligibility criteria, analysis populations, missing-data handling, multiplicity procedures, interim analyses, and a detailed analysis plan are not reported. The record also does not specify the timing, attribution, overlap, or recurrence of the listed adverse events. These gaps constrain assessment of precision, completeness, reproducibility, and the relationship of the recorded events to the device or procedure.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection — NCT02380716.
• Registry record last updated 2026-05-13; status last verified 2026-04.
• Results first posted 2023-02-27.
• 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

ARISE (NCT02380716) is a completed, single-group study sponsored by W.L.Gore & Associates. It evaluated treatment of DeBakey Type I/II aortic dissection with the GORE® Ascending Stent Graft. Enrollment was 21; the study started in 2015-08 and its primary completion date was 2021-02-26. Masking is listed as none.

The primary outcome is all-cause mortality at 30 days post-procedure. Secondary outcomes include technical success, MACCE and its components, aorta-related mortality, device migration, and endoleak. The primary and secondary outcome results are not reported in the registry record, and no analyses are listed.

The adverse-event entry reports 19 participants with a serious adverse event, 9 with an other adverse event, and 6 deaths. The record does not specify whether those deaths occurred within the primary endpoint timeframe. No separate comparator group is identified, so the available information is descriptive rather than a direct treatment comparison.