Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System (NCT05058456), a na na study. The primary outcome is Primary Safety: Major Adverse Events (MAE).

2. Clinical Question

This question is narrower than a comparative test of whether the device improves outcomes. A single-arm feasibility study can describe device use and observed events in its participants, but without a control group it cannot by itself separate outcomes associated with the device from outcomes that might have occurred for other reasons. The registry record says the study was analyzed descriptively and that no statistical significance testing was performed for the standalone study. It also describes a prospectively planned poolability assessment involving a combined analysis cohort with the FORWARD IDE study; results of such an assessment are not reported in the registry record.

3. Trial Design

The registry describes a prospective, multi-center, single-arm feasibility study of the Shockwave Medical Mini S Peripheral IVL System. Its stated purpose was to assess safety and performance when treating heavily calcified, stenotic peripheral arteries. The listed condition is peripheral arterial disease, and the listed intervention is the Shockwave Medical Mini S Peripheral IVL Catheter.

Enrollment was 35. The record gives a start date of 2022-03-16, a primary completion date of 2023-12-19, and a status of COMPLETED. The phase is listed as NA. Allocation is also listed as NA, and masking as NONE. The model is SINGLE GROUP. Together with the single-arm description, these entries indicate that the standalone record does not describe a randomized comparison or a separate control arm.

The primary outcome was a safety endpoint: participants with a major adverse event at 30 days. Secondary outcomes included serious angiographic complications, IVL technical success after post-dilatation, IVL device success, final technical success, major adverse events at 6-months and 12-months post procedure, and primary patency at 12 months. The record lists 9 outcome measures, but the standalone outcome counts and estimates are not reported in the registry record.

The study was analyzed descriptively. The record says the Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study. It also states that no statistical significance testing was performed for the standalone Mini-S study. Further details of the protocol, recruitment, device-use procedures, follow-up completeness, and analysis populations are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: This feasibility study was analyzed descriptively. While the Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study, no statistical significance testing was performed for the standalone Mini-S study results presented in this record. Therefore, no statistical analysis results are available for reporting in the Statistical Analysis sections of the outcome measures.

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: Major Adverse Events (MAE), measured over 30 days.

The primary safety endpoint was the count of participants with a major adverse event within 30 days. The composite included cardiovascular death, clinically driven target lesion revascularization (CD-TLR), and unplanned target limb major amputation above the ankle. The unit was participants, so the intended outcome is the number of people experiencing an event, rather than a rate of events or a time-to-event estimate.

Composite endpoints are used in clinical research to bring several clinically important events into one prespecified outcome. In general, combining events can make a broad safety question easier to summarize, especially when the individual event types are uncommon. However, the components can differ in severity, frequency, and clinical meaning. A composite count does not show which component occurred, how often each component occurred, or whether the components contributed equally to the overall result. Component-level results are needed to answer those questions.

The registry record identifies the endpoint and its 30-day timeframe, but does not report the observed participant count for this primary outcome. It therefore does not support a numerical description of the primary endpoint frequency in this study. Nor does the endpoint alone provide a comparison with outcomes under another treatment or under usual care: the trial is single-arm, and no standalone significance testing was performed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record identifies this study as a single-group, prospective feasibility study and says it was analyzed descriptively. These design features shape the statistical interpretation. Descriptive analysis reports what was observed in the enrolled group. It does not, on its own, test whether outcomes differ from a separate control group or establish a causal treatment effect.

What does a participant count represent?

The primary outcome is defined in terms of participants with at least one event in a composite of cardiovascular death, clinically driven target lesion revascularization, and unplanned target limb major amputation above the ankle. A participant count differs from an event count: one person may have more than one event, while a participant-level endpoint generally counts that person once if they meet the endpoint definition. The registry specifies the unit as participants, but does not report the observed primary count or further counting details.

Counts are often interpreted alongside a denominator, because a count by itself does not convey how common an outcome was in the group being studied. Here, the record lists enrollment of 35 and adverse-event risk sets of 35. It does not report the primary endpoint count, a primary endpoint denominator, or the extent of endpoint follow-up. It would therefore be inappropriate to infer a primary event proportion from the enrollment figure.

Why does the single-arm design matter?

In a randomized comparison, allocation can help make treatment groups comparable in expectation, allowing a between-group contrast to be estimated under the trial design. In a single-arm study there is no concurrent control group. The observed outcomes can describe experience in the enrolled group, but cannot distinguish a device-related effect from underlying disease, participant characteristics, other care, or chance. A comparison with an external group would require additional information and assumptions; no such comparison is reported for the standalone study.

Masking is listed as NONE, while allocation is listed as NA and the model as SINGLE GROUP. These details are consistent with the absence of a randomized two-arm comparison. The record does not describe blinded outcome assessment or other procedures that might affect outcome classification, so those details are not reported in the registry record.

What does descriptive analysis tell readers?

Descriptive analysis can summarize observed counts and, when reported, proportions, distributions, or uncertainty intervals. It can help characterize feasibility and safety observations, but it does not answer a comparative hypothesis unless a suitable comparison and analysis are specified. The registry says no statistical significance testing was performed for the standalone Mini-S study. Therefore, no standalone significance test should be inferred from the registry entries.

A confidence interval is a general statistical tool for describing the uncertainty around an estimate under a specified model and sampling process. A wider interval generally indicates less precision, while a narrower interval indicates more precision under those assumptions. An interval does not guarantee that an estimate is free of bias, and it does not turn a single-arm observation into a comparative result. No primary-endpoint confidence interval is reported in the registry record.

How should the planning assumptions be understood?

The registry's sample-size description concerns a planning illustration computed from an observed effect, not the trial's own design. It specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. For time-to-event tables, the illustration uses total events; for other outcomes, it uses participants per arm. These are planning assumptions, not evidence that the single-arm feasibility study had those design features. In particular, the equal-allocation assumption does not describe the actual study, which is listed as single-group.

Such sample-size illustrations are conditional calculations: they ask what sample size might be needed under selected assumptions for a hypothetical comparison. They are not observed power, do not show that the study was powered for its endpoint, and cannot substitute for the missing primary outcome result. The record does not report a protocol-based sample-size justification for this standalone feasibility study.

Why can over-dispersion matter in general?

General statistical models sometimes assume that outcome variability follows a particular distribution. Over-dispersion means that the observed variability exceeds what the model expects. If it is ignored, uncertainty estimates may be too small and statistical tests may appear more decisive than warranted. Whether over-dispersion is relevant depends on the outcome and analysis model. The registry record does not report a model for the primary endpoint or an over-dispersion assessment, so no such method can be attributed to this trial.

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("Single Arm")
n      <- c(35)
events <- c(1)
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  Single Arm  35  1  2.9  0.1  14.9  0.5  14.5  0.7  14.5

11. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple outcomes: a primary safety endpoint and secondary measures covering angiographic complications, device and technical success, later major adverse events, and patency. When many outcomes are examined, the chance of at least one apparently notable result can increase if each is tested separately. General approaches to multiplicity include prioritizing a prespecified primary outcome, adjusting testing thresholds, or interpreting secondary outcomes as exploratory. The record says the standalone study was analyzed descriptively and that no statistical significance testing was performed. A multiplicity adjustment for standalone testing is therefore not reported in the registry record.

The record states that a Statistical Analysis Plan prospectively described a poolability assessment for a combined analysis cohort across the Mini-S Feasibility study and the FORWARD IDE study. The assessment result and any associated combined analysis are not reported in the registry record. The details of the multiplicity strategy for that assessment, if any, are also not reported in the registry record.

Missing outcome information limits interpretation independently of multiplicity. The registry does not report the primary endpoint count, endpoint-specific missingness, follow-up completeness, or how missing observations were handled. Those omissions prevent assessment of whether all enrolled participants contributed to the primary safety summary and whether incomplete follow-up could affect it. The record also does not describe analysis populations, such as whether analyses included all enrolled participants or only those who received the device. These details are not reported in the registry record, so no particular missing-data method or analysis population should be assumed.

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: peripheral arterial occlusive disease (8.6%), peripheral artery restenosis (8.6%), vascular procedure complications (5.7%), cardiac arrest (2.9%), myocardial infarction (2.9%).

The adverse-event summary lists 18 of 35 participants at risk for serious adverse events and 17 of 35 at risk for other adverse events in the Mini S Peripheral IVL Catheter group. It also lists 4 deaths. These figures describe the adverse-event data recorded for the study group; the record does not specify in this summary whether deaths were included in the serious-event count, how they relate to the primary endpoint, or their causes and timing.

The listed serious terms include Peripheral Arterial Occlusive Disease at 8.6%, Peripheral artery restenosis at 8.6%, Vascular procedure complications at 5.7%, Cardiac arrest at 2.9%, Myocardial Infarction at 2.9%, and Supraventricular Tachycardia at 2.9%. These percentages should be read as term-specific summaries, not as the proportion experiencing any serious adverse event. The record does not give term-level participant counts or explain whether a participant could contribute to more than one term.

These safety figures are not a controlled comparison and do not establish that the device caused or prevented an event. They also do not supply the missing 30-day primary composite count. Timing, severity definitions beyond the listed terms, event adjudication, and follow-up completeness are not reported in the registry record.

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

The registry record describes a completed prospective, multi-center feasibility study of a peripheral IVL catheter, with enrollment of 35 and a primary safety endpoint defined at 30 days. It also reports adverse-event summaries for the single study group. These details establish the broad design and the type of safety information collected.

They do not establish the observed frequency of the primary composite endpoint, because its participant count is not reported in the registry record. Nor do they establish whether the device performs better or worse than another treatment. The study has no separate comparator, and the registry states that no statistical significance testing was performed for the standalone study. The available counts therefore cannot be interpreted as a comparative treatment effect or as evidence of causation.

A feasibility study can provide descriptive information relevant to whether a device has been studied in the intended setting and what types of events were recorded. However, conclusions about the frequency and precision of its primary endpoint require the outcome count and relevant follow-up information. Conclusions about comparative effects require an appropriate comparator and an analysis that accounts for the study design. Neither can be reconstructed from the registry record's design and adverse-event figures alone.

The record's mention of a planned poolability assessment with the FORWARD IDE study does not itself establish that pooling occurred or that a combined result supports any conclusion. The assessment and combined results are not reported in the registry record. A careful reading is therefore descriptive and bounded: the record identifies the feasibility study, its endpoint and selected safety summaries, while leaving the primary result and comparative interpretation unresolved.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of the distinction between feasibility evidence and comparative evidence. Its prospective, multi-center, single-arm design allows outcomes to be described for a group receiving the device, but it does not provide a concurrent control for estimating a between-group contrast. That distinction matters whenever safety counts are read as evidence about a treatment effect.

The primary endpoint also illustrates the interpretive trade-off involved in a composite outcome. Combining cardiovascular death, clinically driven target lesion revascularization, and unplanned target limb major amputation above the ankle creates one broad safety measure. But an overall composite count would not, by itself, show the contribution or clinical profile of each component. Here, the count itself is not reported in the registry record, so even the overall 30-day endpoint cannot be quantified from the available record.

The adverse-event summary shows why denominators, event definitions, and follow-up matter. The listed counts and term-specific percentages describe safety reporting, but they do not provide a randomized comparison or clarify every event's timing, relationship to the primary endpoint, or possible overlap across terms. Without those details, the summaries should not be treated as estimates of causal risk.

Finally, the record refers to a planned poolability assessment involving another study while also stating that standalone analysis was descriptive and lacked significance testing. This highlights that planned combined analyses and standalone results are different inferential questions. The poolability assessment and combined findings are not reported in the registry record. Readers should distinguish what the record says was planned from what it reports as an observed result.

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 the main safety question is that the registry record does not report the observed count for the 30-day composite endpoint. It also does not report a confidence interval or other measure of precision for that outcome. As a result, the primary safety result cannot be quantified from the record.

The single-arm design has no concurrent control group. The observed adverse-event counts therefore cannot establish how outcomes compare with another device, procedure, or care approach, and cannot isolate the effect of the study device. The registry explicitly states that no statistical significance testing was performed for the standalone study.

Further limitations arise from missing methodological detail. Eligibility criteria, baseline characteristics, endpoint follow-up completeness, event adjudication procedures, missing-data handling, and analysis populations are not reported in the registry record. These omissions limit assessment of who contributed to each outcome and how reliably events were classified. The record lists 9 outcome measures but does not report their standalone results.

The registry notes a planned poolability assessment involving the FORWARD IDE study, but does not report the assessment result or any combined analysis. The rationale and detailed statistical procedures for such an analysis are not reported in the registry record. The adverse-event terms and counts are useful descriptive information, but the record does not clarify timing or overlap among terms or the relationship of the listed deaths to the primary composite. These limitations constrain both precision and clinical interpretation.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System — NCT05058456.
• Registry record last updated 2026-08-03; status last verified 2026-07.
• Results first posted 2025-06-08.
• 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

NCT05058456 is a completed, prospective, multi-center, single-arm feasibility study of the Shockwave Medical Mini S Peripheral IVL System for heavily calcified, stenotic peripheral arteries. The registry lists peripheral arterial disease as the condition, enrollment of 35, and the Mini S Peripheral IVL Catheter as the intervention. The study start date is 2022-03-16, and the primary completion date is 2023-12-19.

The primary endpoint was participants with a major adverse event at 30 days, defined as a composite of cardiovascular death, clinically driven target lesion revascularization, and unplanned target limb major amputation above the ankle. Its observed count is not reported in the registry record. The record lists secondary measures related to complications, technical and device success, later major adverse events, and patency.

The study was analyzed descriptively, with no statistical significance testing for the standalone study. The registry reports selected adverse-event counts and terms, and notes a planned poolability assessment with the FORWARD IDE study; results of that assessment are not reported in the registry record.