Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease (NCT05755711), a registered phase not stated study. The primary outcome is Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF).

2. Clinical Question

The study is titled “Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease” and is registered as NCT05755711. Its stated focus is women with calcified coronary artery disease undergoing PCI with coronary IVL and stenting. The registry describes the project as post-market, prospective, multicenter, and observational, with a single arm. Enrollment is 399.

The primary question is framed as a safety assessment of TLF after the procedure, not as a randomized comparison of IVL with another treatment. The registry also lists secondary outcomes involving angiographic and procedural success, serious angiographic complications, TLF at later follow-up times, and major adverse cardiac events at 30 days. Those outcomes provide additional areas of observation, but their results are not reported in the registry record. The record does not report a separate question comparing outcomes by demographic or clinical subgroup.

3. Trial Design

This is a post-market, prospective, multicenter, single-arm observational study sponsored by Shockwave Medical, Inc. The registry describes its aim as generating real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease. Enrollment is 399. The study began on 2023-05-03, and the primary completion date is 2024-12-11. Its status is active, not recruiting.

The arm is described as female subjects referred for PCI with coronary IVL and stenting per standard of care. The listed intervention is the Shockwave Medical Coronary IVL System. Because the design is single-arm, the registry record does not provide a separate untreated or alternative-treatment group for a direct comparison. Allocation is not stated in the registry record. The record therefore does not describe random assignment or a concurrent control comparison.

The primary outcome is a participant count for TLF within 30 days of the index procedure. The registry defines the composite using cardiac death, target-vessel myocardial infarction, and ischemia-driven target lesion revascularization. Secondary outcomes include angiographic success at residual-stenosis thresholds of ≤30% and <50%, procedural success, serious angiographic complications, TLF at 1 year, 2 year, and 3 year, and major adverse cardiac events at 30 days. The registry lists 35 outcome measures overall.

Details such as eligibility criteria beyond the arm description, the number and locations of participating centers, follow-up procedures, and the prespecified statistical analysis plan are not reported in the registry record. The registry lists 0 analyses. The design can describe outcomes observed among enrolled participants, but without a comparator it cannot by itself separate the association with IVL from the effects of other care or participant characteristics.

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 Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF), measured over within 30 days of index procedure.

The primary safety endpoint counts participants with target lesion failure within 30 days of the index procedure. TLF is a composite: cardiac death, myocardial infarction attributable to the target vessel, or ischemia-driven target lesion revascularization. The registry specifies the myocardial infarction definitions: the SCAI definition for peri-procedural MI and the 4th Universal Definition for spontaneous MI beyond discharge.

A composite endpoint combines clinically different events into a single outcome measure. It can capture several kinds of failure relevant to the treated lesion and vessel, but a combined count does not by itself show how much each component contributed. Component-specific results would be needed to interpret the mix of events; those results are not reported in the registry record.

The registry’s use of a participant count indicates that the endpoint is framed around whether participants experienced an event, rather than as a continuous measurement. In general, a count can be interpreted alongside the number of participants assessed, but the endpoint result and its analysis are not reported in the registry record. The short, specified follow-up window makes this a measure of early safety after the index procedure, not a complete account of later outcomes. The registry separately lists TLF at 1 year, 2 year, and 3 year as secondary outcomes.

TLF is used as a composite safety outcome because it gathers events related to death, myocardial injury, and repeat intervention into a defined endpoint. That general rationale does not make the components interchangeable: each has a different clinical meaning, and the registry definition determines which events qualify.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is binary at the participant level: a participant either meets the composite TLF definition within the specified follow-up window or does not. General statistical interpretation of a binary endpoint often uses the number of participants with the event relative to the number assessed. The registry record does not report the primary endpoint count or the number assessed for that endpoint, so an event proportion cannot be read from this record.

A confidence interval is a way to express the statistical precision of an estimate. In general, a wider interval indicates less precision, while a narrower interval indicates more precision, subject to the assumptions of the method used. The registry record does not report a confidence interval for the primary endpoint or name an interval method. Without an estimate and its interval, the amount of uncertainty around the primary result cannot be assessed from the registry record.

A hypothesis test, when used, evaluates data against a specified null hypothesis under a statistical model. Its p-value is not a measure of the size or clinical importance of an effect, and it does not establish causality. No primary-endpoint p-value, hypothesis test, or inferential model is reported in the registry record. The record lists 0 analyses. It is therefore not possible to characterize the primary endpoint as statistically significant or nonsignificant from this information.

The study is single-arm and observational. In general, a single-arm event count can describe the observed experience of that group, but it cannot directly estimate a treatment contrast against a concurrent control group. Comparisons with external benchmarks can also be affected by differences in population, care, follow-up, and outcome definitions. The registry does not state a benchmark comparison or a method for adjusting for such differences. Allocation is not stated in the registry record, and the study is not a randomized comparison.

TLF is a composite endpoint. For a composite, the combined outcome can be statistically convenient and can reflect several important event types, but its interpretation depends on the components. A combined result does not show whether events were chiefly cardiac deaths, target-vessel MIs, or ischemia-driven revascularizations. The registry provides the component definitions but does not report component counts or component-specific analyses. In general, the event definitions and the follow-up window should be considered together when interpreting a composite.

The registry specifies the timeframe for the primary endpoint as within 30 days of the index procedure. It also lists TLF at 1 year, 2 year, and 3 year as secondary outcomes. These follow-up periods answer different descriptive questions: early events and later events are not interchangeable measures. Time-to-event analysis can account for differing follow-up durations when appropriately specified, but the registry record does not report the methods used for later TLF outcomes, censoring, or follow-up completeness.

The sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. For time-to-event tables, the illustration uses a total event count under the Schoenfeld method; for other outcomes, it expresses participants per arm. These are planning assumptions, not the study’s own design justification and not observed power. The record does not report a sample-size justification for this single-arm study, and no planning illustration can replace an analysis of observed data.

In general, over-dispersion arises when variability in data exceeds what a chosen statistical model expects. It matters because a model that understates variability can produce overly narrow intervals or misleading tests. This concept is most directly relevant to count or clustered data under particular models; the primary endpoint is described as a participant count for a binary composite. The registry record does not report a model or a dispersion assessment, so no claim about over-dispersion in this study is possible.

Multiplicity concerns arise when several outcomes or comparisons are assessed. Testing many outcomes can increase the chance of at least one apparently notable result under a set of null hypotheses. General approaches include prespecifying a primary outcome and controlling error across a family of tests, but the appropriate approach depends on the analysis plan and aims. The registry lists 35 outcome measures and 0 analyses, but does not report a multiplicity strategy or the ordering and inferential status of secondary outcomes. The primary endpoint is identified as a safety endpoint; that label alone does not establish a statistical testing procedure.

Analysis populations also matter. An intention-to-treat population generally refers to participants analyzed according to their assigned group, but this study is single-arm and the registry record does not report the detailed population rules used for the primary endpoint. It identifies an ITT group in adverse-event reporting, but that does not establish the endpoint-specific analysis population. The handling of missing endpoint data, exclusions, deviations, and incomplete follow-up is not reported in the registry record.

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("Intent-to-Treat (ITT)")
n      <- c(397)
events <- c(46)
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  Intent-to-Treat (ITT)  397  46  11.6  8.6  15.2  8.8  15.1  8.8  15.1

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 35 outcome measures, including a primary safety endpoint and secondary outcomes covering angiographic success, procedural success, serious angiographic complications, TLF at later follow-up, and MACE at 30 days. It lists 0 analyses. No statistical plan explaining how results across these outcomes would be interpreted is reported in the registry record.

In general, multiplicity becomes relevant when multiple outcomes or hypotheses are assessed, because repeated testing can increase the chance of a false-positive finding. A prespecified hierarchy or adjustment can address some multiplicity concerns, but the choice depends on the study objectives and analysis plan. Neither a multiplicity adjustment nor a testing hierarchy is reported in the registry record. Since outcome results and analyses are not reported, there is no basis for assessing how multiplicity affected any findings.

The registry does not report how missing endpoint observations were handled, whether follow-up was complete, or how participants with incomplete data were treated in the primary analysis. It also does not report a primary-endpoint analysis population definition. The adverse-event record identifies an ITT group, but that label alone does not establish the population used for the primary endpoint or the rules for including participants in each analysis.

These omissions limit evaluation of completeness and potential bias. Missing observations can affect interpretation if the probability of missingness is related to outcomes or participant characteristics; this is a general statistical concern, not a claim about what happened in this study. The registry record does not provide enough information to assess the extent or handling of missing data.

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 2.5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: angina pectoris (2.3%), coronary artery dissection (1.5%), cardiac failure (1.3%), hypotension (1.3%), acute myocardial infarction (1.0%).

The adverse-event record identifies an Intent to Treat (ITT) group and reports 399 at risk for both the serious and other adverse-event categories. It reports 88 participants affected by serious adverse events and 21 affected by other adverse events. The recorded number of deaths is 8. These figures describe the registry’s event reporting; they are not the primary endpoint result.

The listed serious-event terms and percentages are angina pectoris, 2.3%; coronary artery dissection, 1.5%; cardiac failure, 1.3%; hypotension, 1.3%; acute myocardial infarction, 1.0%; and atrial fibrillation, 1.0%. The registry record does not provide additional context about event timing, severity grades, relatedness to the device or procedure, or whether participants experienced more than one event. The percentages should therefore be read as the registry’s reported values for the listed terms, not as a complete account of each participant’s overall experience.

In general, adverse-event counts and the TLF composite answer different questions. TLF is specifically defined using cardiac death, target-vessel MI, and ischemia-driven target lesion revascularization within 30 days; adverse-event reporting covers a broader set of reported events. The registry record does not explain overlap between adverse-event categories, deaths, and TLF, so these counts should not be combined or treated as mutually exclusive.

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

The registry record establishes that a prospective, multicenter, single-arm observational study was designed to collect real-world clinical evidence associated with coronary IVL among female subjects with calcified coronary artery disease. It specifies PCI with IVL and stenting per standard of care, and defines a primary safety endpoint based on TLF within 30 days of the index procedure. These details clarify the population, care setting, and outcome the study was intended to assess.

The record does not report the primary endpoint result, a confidence interval, or an analysis of that endpoint. It therefore does not show the observed frequency or precision of TLF in the study. The registry also does not report results for its listed secondary outcomes. The adverse-event counts are reported separately and should not be substituted for the primary endpoint.

Even with complete results, a single-arm observational study would describe events among its participants rather than provide a direct randomized comparison. In general, observed outcomes in such a study may reflect the procedure, other care, participant characteristics, and the clinical setting. The record does not include an alternative-treatment control arm or an analysis that separates these influences. Accordingly, the design alone cannot establish a causal treatment effect or support a comparative claim.

The composite endpoint brings several event types together, but its total would not reveal the contribution of each component unless those results were separately reported. The registry provides definitions for the component events, while component-specific results are not reported in the registry record. The listed later TLF timepoints and other secondary outcomes also have no reported results in the record.

The appropriate reading is therefore narrow: the registry describes a study question and design, and records adverse-event counts, but does not provide the primary endpoint analysis needed to characterize the study’s TLF findings. This is not evidence that an outcome did or did not occur beyond the counts explicitly recorded, nor a basis for a conclusion about treatment effectiveness.

14. Why This Trial Matters Statistically

This study addresses an important statistical setting: real-world evidence for a device used during PCI in women with calcified coronary artery disease. Its stated population focus is explicit, and its endpoint is defined around early safety after the index procedure. Those features make it possible to identify what the study intends to measure and the clinical context in which the observations arise.

The design also illustrates why a clearly specified outcome is not enough to support every kind of inference. TLF is defined as a composite, with named event components and a stated follow-up window. That improves clarity about what counts as an endpoint event. Yet interpretation still depends on the observed count, the number assessed, precision, component-level results, and the analysis methods. These results and methods are not reported in the registry record.

Its single-arm observational structure is central to statistical interpretation. Such a design can contribute descriptive evidence about observed outcomes in the enrolled population, but it does not provide a direct control-group contrast. That distinction matters when readers consider whether outcomes can be attributed to the device or compared with another approach. The registry record does not report a comparative analysis.

The study also lists a broad set of secondary outcomes and later follow-up measures. In general, multiple outcomes raise questions about multiplicity, missing follow-up, and how analyses are prioritized. Here, the registry lists 35 outcome measures and 0 analyses, while the multiplicity and missing-data methods are not reported. These gaps make it especially important to distinguish a registered outcome framework from analyzed results.

Statistically, the record is useful for understanding the intended safety question and study design, while also illustrating the limits of interpretation when endpoint findings and analysis details are absent. Its contribution cannot be judged from the endpoint definition and enrollment alone.

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 interpreting this registry record is that it does not report the primary TLF result or its precision. The number assessed for that endpoint, any confidence interval, and any inferential analysis are also not reported. As a result, the frequency and uncertainty of the primary safety outcome cannot be evaluated from the record.

The study is single-arm and observational, with no like-for-like control comparison in the registry record. Allocation is not stated. This prevents direct estimation of a comparative treatment effect from the registered design and limits causal interpretation of any observed outcomes. The intervention occurs with PCI and stenting per standard of care, so outcomes are observed in a broader care context.

The endpoint is composite, but component-specific results are not reported. The record also lists secondary measures, including angiographic success, procedural success, serious angiographic complications, later TLF, and MACE, without reporting their results. The registry does not report a multiplicity plan, missing-data methods, follow-up completeness, or endpoint-specific analysis populations.

Further design details that could help assess generalizability and conduct are not reported in the registry record, including detailed eligibility criteria, the participating-center information, and the prespecified statistical analysis plan. Enrollment and study status alone do not resolve these limitations. The adverse-event counts are useful as recorded, but the record does not explain overlap with the primary endpoint, event relatedness, or whether the listed adverse-event categories are mutually exclusive.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease — NCT05755711.
• Registry record last updated 2026-07-30; status last verified 2026-03.
• Results first posted 2026-01-22.
• 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

NCT05755711 is a post-market, prospective, multicenter, single-arm observational study sponsored by Shockwave Medical, Inc. It concerns female subjects with calcified coronary artery disease referred for PCI with coronary IVL and stenting per standard of care. Enrollment is 399. The study began on 2023-05-03, has a primary completion date of 2024-12-11, and is listed as active, not recruiting.

The primary safety endpoint is the number of participants with TLF within 30 days of the index procedure. TLF is defined as cardiac death, target-vessel MI, or ischemia-driven target lesion revascularization. The primary endpoint result and its statistical analysis are not reported in the registry record. The registry lists 35 outcome measures and 0 analyses.

Adverse-event reporting identifies an ITT group, with 399 at risk for serious and other events, 88 participants affected by serious adverse events, 21 affected by other adverse events, and 8 deaths. These reports do not substitute for the missing primary endpoint findings or a controlled comparison.