Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access (NCT05399680), a na na study. The primary outcome is Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome).

2. Clinical Question

The investigation’s stated objective combines acute safety and efficacy for device use in patients receiving treatment for obstructive arterial disease. The primary endpoint focuses specifically on major complications at the radial access site, rather than on every possible complication or on the broader clinical course of arterial disease. Its attribution requirement also matters: the endpoint definition includes complications attributed to the study device or procedure, as adjudicated by a clinical events committee (CEC).

The study is not framed as a test of one treatment against another. In a single-group study, the endpoint can describe what was observed among participants treated with the device system, but it cannot by itself estimate how outcomes would have differed under a separate treatment or access strategy. The registry record does not report an observed primary endpoint result, so the central safety question cannot be answered from the posted outcome information.

3. Trial Design

This is a completed, single-group device study with no masking. Allocation is listed as not applicable, and the record does not describe a randomized comparison. The listed intervention combines the S.M.A.R.T. RADIANZ™ Vascular Stent System with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter. The stated purpose is to evaluate acute safety and efficacy when these devices are used to deploy a nitinol stent for obstructive iliac or femoropopliteal arterial disease through radial access.

The record reports enrollment of 151. It separately identifies main and roll-in cohorts in the adverse-event information, with 129 participants at risk for the listed main-cohort safety summaries and 22 at risk for the roll-in summaries. Those cohorts are not presented as randomized arms or as a like-for-like control comparison. The primary endpoint population is the intent-to-treat population of the main cohort. The registry record does not give further detail about cohort assignment or the relationship of roll-in participants to the main analysis.

The study started on 2022-06-29, reached primary completion on 2023-09-22, and is listed as completed. The primary endpoint’s observation period begins at sheath introduction through the radial artery and ends at hospital discharge, within approximately 48 hours after the procedure, or at study exit, whichever comes first. Several secondary outcomes concern device deficiencies, adverse events, death, index-limb amputation, target lesion revascularization, procedural complications, and technical or procedural success. The registry record lists 17 outcome measures but does not report numerical results for the primary endpoint or those secondary outcomes.

Because no randomized control group is described, the design primarily supports a descriptive account of outcomes among treated participants. A single-group study can document events observed during a defined follow-up period, but it cannot separate an intervention effect from other explanations for those outcomes. The registry record does not report a statistical analysis plan, the rationale for the enrollment target, or details of any interim analyses.

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 151 total enrolled subjects, 129 subjects belonged to the main cohort while the remaining 22 subjects belonged to a roll-in cohort. The outcomes presented in this record are for EACH of the two cohorts in the Participant Flow, Baseline Characteristics and Adverse Events modules and for the MAIN cohort alone in all other modules (i.e., Outcome Measures).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent-to-treat population of the main cohort

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 Occurrence Rate of Radial Access Site Complications (Primary Safety Outcome), measured over From the time of sheath introduction through the radial artery (start time of procedure) through time of discharge (within ~48 hours of end time of procedure) or study exit, whichever comes first.

The primary endpoint is the occurrence rate of CEC-adjudicated major radial access site complications attributed to the study device or procedure. It is defined as a count of participants, so its intended summary is how many participants in the specified population experienced an event meeting the definition. The population is the intent-to-treat population of the main cohort.

The time window starts with introduction of the sheath through the radial artery and continues through hospital discharge, within approximately 48 hours after the end of the procedure, or study exit, whichever occurs first. The endpoint therefore concerns acute complications during the procedure and the specified early period, not events over long-term follow-up. The requirement for CEC adjudication indicates that event qualification involves committee review; the registry record does not provide adjudication procedures or criteria beyond the endpoint description.

As a general statistical concept, a safety endpoint focused on access-site complications can organize reporting around events plausibly associated with the access route, device, or procedure. A participant count is readily interpretable, but it does not by itself convey precision or allow comparisons without an appropriate comparator and compatible follow-up. The occurrence rate and its uncertainty would help readers understand how precisely the event frequency was estimated. Neither the observed primary count nor an interval estimate is reported in the registry record.

The registry record also does not report how missing outcome assessments were handled, whether all main-cohort participants had complete follow-up through the endpoint window, or what specific event-level rules were used to decide whether a complication met the definition. These omissions limit interpretation of the endpoint beyond its stated population, attribution, adjudication, and time frame.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a participant count represent?

The primary endpoint is specified as a count of participants with a qualifying event. In general, this kind of binary outcome records whether each participant did or did not experience the defined event during the specified observation period. A participant-level count is different from an event count: one participant may experience more than one event, while a participant-level summary may count that person once if the endpoint definition is based on occurrence. The registry record identifies the primary measure as a participant count, but does not report its observed value or additional rules for multiple events.

The endpoint definition also limits which events qualify. It calls for a major radial access site complication, CEC adjudication, and attribution to the study device or procedure. These restrictions make clear that not every adverse event automatically belongs in the primary endpoint. The registry record does not provide further adjudication guidance, so the exact operational details cannot be assessed from this description alone.

Why does the observation window matter?

An event frequency depends on the time during which participants are observed. The primary window runs from sheath introduction through discharge, within approximately 48 hours after the procedure, or study exit, whichever comes first. This makes the endpoint an acute safety measure. It does not describe the frequency of later events over extended follow-up. In general, comparisons of event frequencies are interpretable only when the populations, definitions, and observation periods are sufficiently aligned.

The endpoint’s stopping rule also means observation time may not be identical for every participant if discharge or study exit occurs at different times. The record does not report individual follow-up durations or how incomplete observation was handled. No assumption about completeness should be made from the endpoint description alone.

What can a confidence interval add?

In general, a confidence interval describes the statistical uncertainty around an estimate under a stated method. It helps readers distinguish a relatively precise estimate from one that remains compatible with a broad range of underlying event frequencies. An interval does not remove design limitations, correct missing information, or make a single-group study equivalent to a randomized comparison. No primary endpoint confidence interval is reported in the registry record, so precision cannot be evaluated for that outcome.

For a binary outcome, uncertainty is influenced by the number of participants observed and by how many meet the event definition. The registry record supplies the main-cohort population for the primary endpoint but not the qualifying event count. It is therefore not possible to characterize the primary estimate’s statistical uncertainty from the stated endpoint description. No new estimate should be inferred from unrelated adverse-event summaries.

Why does the single-group design constrain inference?

In general, a concurrent randomized comparator helps distinguish differences associated with treatment assignment from differences that may arise from participant characteristics, clinical course, or other factors. This study is listed as single-group, with allocation not applicable and no masking. The record does not describe a randomized control group. Thus, even a reported event frequency would describe outcomes in the studied group rather than establish what would have happened under an alternative treatment or access strategy.

The main and roll-in cohort summaries do not change this design constraint. The registry record does not present those cohorts as randomized treatment groups. A contrast between their counts would not be a controlled treatment-effect estimate and should not be interpreted as one.

How should planning illustrations be understood?

In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, statistical significance threshold, allocation, and analysis method. It does not indicate that a study had a particular probability of detecting its observed result, and it is not a summary of observed outcomes. The record describes planning illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. It distinguishes participant-per-arm illustrations from total-event illustrations for time-to-event settings.

Those stated assumptions do not make this single-group study a two-arm randomized trial. The planning illustration is not evidence of an actual comparator or of the trial’s original design rationale. The registry record does not report the sample-size illustration results or the study’s own sample-size justification. No planning value should be mistaken for an observed participant count, an observed effect, or observed power.

What role do adverse-event classifications play?

In general, serious and other adverse-event summaries are classifications used to describe safety information; they are not interchangeable with a prespecified primary endpoint. A serious adverse event need not meet the primary endpoint’s anatomical, attribution, timing, and adjudication requirements. Conversely, the record does not provide enough detail to determine how every serious adverse event relates to the primary endpoint. The listed adverse-event counts should therefore remain distinct from the unreported primary outcome.

Similarly, percentages listed alongside serious-event terms do not supply a complete event profile by themselves. Without the associated event counts and denominator definition, readers cannot reconstruct term-level counts or determine overlap. The registry record’s term percentages should be quoted as reported rather than used to derive new quantities.

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("Interventional")
n      <- c(129)
events <- c(0)
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  Interventional  129  0  0.0  0.0  2.8  0.0  2.9  0.0  2.8

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 17 outcome measures, spanning the primary safety endpoint and secondary outcomes that include device deficiencies, adverse events, death, index-limb amputation, target lesion revascularization, procedural complications, and device-related technical or procedural success. Considering multiple outcomes can create a multiplicity issue: in general, the more statistical questions examined, the greater the chance that at least one result appears notable by chance if each is judged separately. The record does not report an adjustment strategy, a hierarchy for interpreting outcomes, or a statistical analysis plan. It also lists 0 analyses, so no analysis-specific estimates or tests are available in the record.

The absence of reported analyses does not show that analyses were or were not conducted outside the registry entry. It means the registry record does not supply the information needed to evaluate how the listed outcomes were analyzed, whether comparisons or hypothesis tests were prespecified, or whether any multiplicity control was used. No inferential conclusion should be attributed to unreported tests.

The primary endpoint population is the intent-to-treat population of the main cohort. The record does not explain how this population was operationalized, whether participants were excluded after enrollment, or how the analysis handled missing outcome data or incomplete follow-up. It does not report the number of participants with missing primary endpoint status or any imputation or sensitivity-analysis approach. These details are not reported in the registry record.

In general, missing outcome information can affect a binary event estimate when participants without observed status differ from those with observed status. A clear account of completeness and handling is needed to judge that possibility. The endpoint’s stated time window and population are useful definitions, but they do not resolve missing-data questions. The separate adverse-event risk counts are not a substitute for a reported flow of participants through the primary analysis.

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: acute myocardial infarction (9.1%), iliac artery perforation (4.5%), ulcer (4.5%), wound complication (4.5%), haemoglobin decreased (4.5%).

The adverse-event summaries distinguish the main cohort from the roll-in cohort. In the main cohort, 5 of 129 participants are listed with serious adverse events and 10 of 129 with other adverse events; deaths are listed as 0. In the roll-in cohort, 6 of 22 are listed with serious adverse events and 0 of 22 with other adverse events; deaths are listed as 1. These are descriptive figures, not the primary endpoint result.

The record also lists serious-event terms with percentages: acute myocardial infarction, 9.1%; iliac artery perforation, 4.5%; ulcer, 4.5%; wound complication, 4.5%; haemoglobin decreased, 4.5%; and rectal hemorrhage, 0.8%. The registry record does not give the event counts or denominator details for these term-level percentages. They cannot be converted into counts or added to produce a total. Nor does the record clarify whether one participant could contribute more than one term.

In general, serious adverse events and the primary safety endpoint are different concepts. The primary endpoint is restricted to CEC-adjudicated major radial access site complications attributed to the study device or procedure during its defined acute window. The serious-event summaries have broader labels and the registry record does not map individual serious events onto the primary endpoint. The main and roll-in cohorts are not a randomized comparison, so their figures should not be interpreted as evidence that one group’s treatment was safer.

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

The registry record describes a device investigation focused on acute safety and efficacy for radial-access treatment of obstructive iliac or femoropopliteal arterial disease. It specifies a primary safety outcome based on CEC-adjudicated major radial access site complications attributed to the device or procedure, in the main-cohort intent-to-treat population and during the period through discharge or study exit. These details clarify what the outcome was intended to capture.

However, the registry record does not report the primary endpoint’s observed participant count or occurrence rate. It also does not provide an interval estimate for that endpoint. As a result, the posted information cannot quantify how often the defined complication occurred or how precisely its frequency was estimated. The event definition should not be mistaken for evidence of a particular outcome.

The adverse-event listings supply additional safety descriptions, including serious-event counts, other-event counts, deaths, and selected serious-event terms with percentages. These summaries can be read as registry-reported descriptive information, but they are not a substitute for the primary endpoint result. The record does not provide all context needed to reconcile the term percentages with cohort-level counts or the primary endpoint definition.

In general, a single-group study can describe outcomes among people treated under the study conditions. Without a randomized comparator, it cannot establish the difference that would have occurred under an alternative treatment or access approach. The roll-in cohort is not identified as a control group, and the registry record specifically describes the study as single-group. Accordingly, cohort differences should not be treated as comparative treatment effects.

The findings that can be stated are limited to the design, endpoint definition, and adverse-event summaries actually reported. The record does not report the primary outcome result, detailed statistical analyses, missing-data handling, or a multiplicity strategy. Those absences prevent a fuller assessment of the strength and precision of evidence for the stated primary question.

14. Why This Trial Matters Statistically

This study raises a clinically specific statistical question: how often do major radial access site complications, meeting a defined adjudication and attribution standard, occur during the acute period after use of a particular device system? A narrowly defined endpoint can make safety reporting more interpretable by identifying the event type, relevant population, and observation window. The registry record states each of those elements for the primary outcome.

The statistical importance of reporting the result is substantial. A participant count and occurrence rate would describe the observed frequency, while an uncertainty interval would show how much precision the data support. The registry record does not report those primary outcome results. Without them, the endpoint’s definition cannot be translated into an estimate of acute complication frequency.

The single-group design also makes careful wording important. Descriptive event counts can be informative about what was reported among treated participants, but they do not provide a randomized estimate of a treatment difference. The separate roll-in cohort cannot be treated as a control group on the available record. Recognizing this distinction prevents a descriptive safety summary from being overstated as comparative evidence.

Finally, the registry record illustrates why endpoint results need supporting analysis details. The list of outcome measures, the named intent-to-treat population, and the safety summaries do not disclose how missing outcomes were handled, whether multiplicity was addressed, or what statistical methods were used for the primary endpoint. Such information matters for understanding not only the estimate, but also its uncertainty and the scope of conclusions it can support. In this record, these aspects 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 most immediate limitation is that the registry record defines the primary safety endpoint without reporting its observed result. No primary count, occurrence rate, or confidence interval is given. The main question about the frequency of CEC-adjudicated major radial access site complications therefore remains unanswered by the posted results.

The study is single-group, with allocation listed as not applicable and no masking. The record does not describe a randomized comparator. This design can support descriptive reporting but does not establish a causal contrast with another treatment or access strategy. The roll-in cohort is reported separately in the adverse-event summaries, but the record does not identify it as a control group.

The record does not report a statistical analysis plan, an analysis of the primary outcome, a multiplicity approach, or methods for handling missing endpoint data. It also does not provide a participant flow account or details on completeness of follow-up for the primary endpoint. These omissions make it difficult to judge how the stated analysis population was implemented and how robust an estimate would be to missing information.

Term-level serious-event percentages are listed without event counts or denominator details in the registry record. Their relationship to the cohort-level serious-event summaries and to the primary endpoint is not explained. It is therefore not possible to reconstruct term counts or determine overlap from the reported percentages.

The record lists enrollment of 151 and separate adverse-event risk populations for the main and roll-in cohorts. It does not explain the cohort assignment process or provide further information that would support a direct comparison between them. The registry record also does not report the study’s own sample-size justification. Planning illustrations described in the record are not a substitute for that rationale or for observed outcome estimates.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access — NCT05399680.
• Registry record last updated 2025-08-11; status last verified 2025-02.
• Results first posted 2025-08-11.
• 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

This completed, single-group device study evaluates the S.M.A.R.T. RADIANZ™ Vascular Stent System with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter for treatment of obstructive iliac or femoropopliteal arterial disease through radial access. Enrollment is listed as 151. The study started on 2022-06-29, and primary completion is listed as 2023-09-22.

The primary outcome is the occurrence of CEC-adjudicated major radial access site complications attributed to the study device or procedure, in the main-cohort intent-to-treat population, from sheath introduction through discharge or study exit. The registry record does not report the primary outcome result. Adverse-event summaries are listed separately for the main and roll-in cohorts; they are descriptive and do not constitute a randomized comparison. The record does not report analysis details, missing-data handling, or a multiplicity strategy.