SELUTION SLR™ 014 In-stent Restenosis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for SELUTION SLR™ 014 In-stent Restenosis (NCT04280029), a randomized na study. The primary outcome is Number of Participants With Target Lesion Failure (TLF).

2. Clinical Question

In-stent restenosis is the clinical condition named in the trial record. The treatment comparison asks whether outcomes after the drug-eluting balloon are assessed against outcomes after a mixture of standard-care approaches, rather than against a single intervention used for every comparator participant. That distinction matters when interpreting the contrast: the Standard of Care group could include contemporary stents or balloon angioplasty, according to the trial description.

The primary outcome is a count of participants meeting a composite definition, not a measure of the degree of narrowing or a continuous change in vessel size. The posted result records 32 participants with target lesion failure in the SELUTION group and 28 in the Standard of Care group. Those counts belong to the stated per-protocol analysis population. They should not be read as the full randomized-group counts or as the result of an intention-to-treat analysis.

The question is therefore narrower than whether either treatment is generally effective or safe. It concerns a specified composite outcome, at a specified follow-up time, in the reported analysis population and against the comparator strategy recorded for this study. The result describes the observed comparison; by itself, it does not establish a noninferiority conclusion.

3. Trial Design

The registry describes a prospective, randomized, controlled, single-blind, multicenter, parallel-group study. The allocation is recorded as randomized, and the brief summary states that eligible participants were assigned in a 1:1 ratio to SELUTION SLR 014 DEB or Standard of Care. The masking entry says single blind, but which parties were masked is not reported in the registry record.

The registry lists an enrollment of 418. This is the recorded enrollment figure, while the primary endpoint result uses per-protocol analysis populations of 197 participants in the SELUTION group and 193 in the Standard of Care group. These figures refer to different aspects of the record and should not be substituted for one another. The reason the per-protocol populations differ from the enrollment figure is not reported in the registry record.

The study started on 2020-07-06, has a primary completion date of 2025-08-15, and is listed as active, not recruiting. These are registry status and timing details; they do not explain how participants were followed or how the primary outcome was analyzed beyond the recorded 12-month timeframe and per-protocol population.

The intervention is a sirolimus-coated drug-eluting balloon. The comparator is Standard of Care, described as contemporary drug-eluting stents or balloon angioplasty. The brief summary specifies zotarolimus-eluting and everolimus-eluting stents and limits balloon angioplasty to a maximum of 20% of participants randomized to Standard of Care. The precise distribution of comparator procedures among participants is not reported in the registry record.

The primary endpoint is target lesion failure at 12 months after the index procedure. Secondary outcomes listed in the record include device, lesion, and procedure success; safety composites; target-vessel revascularization; target lesion failure; target vessel failure; and net adverse clinical events. The registry labels the study noninferiority, but the noninferiority margin, original sample-size rationale, and detailed statistical design assumptions 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: For the primary endpoint, the analysis population is Per Protocol. The Per Protocol population is 197 participants for the SELUTION SLR 014 DEB group and 193 participants for the Standard of Care group.

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.

Population: The primary analysis population is Per Protocol. The Per Protocol population is 197 participants for the SELUTION SLR 014 DEB group and 193 participants for the Standard of Care group.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Target Lesion Failure (TLF), measured over 12 months post-index procedure.

Target lesion failure is a composite endpoint assessed 12 months after the index procedure. The registry defines it as cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization. Myocardial infarction includes spontaneous Type 1 MI using the 4th Universal Definition of Myocardial Infarction and peri-procedural MI using the Society for Cardiac Angiography and Intervention definition.

A composite endpoint brings several clinically relevant events together into one outcome. In general, this can provide a broader summary of events related to the target lesion than any one component alone. It also means the overall result does not show which component contributed most. Component-specific primary endpoint counts are not reported in the registry record.

The posted measure is the number of participants with target lesion failure, so it is a binary participant-level outcome: each participant either meets the composite definition or does not during the stated assessment period. The registry reports 32 participants with the endpoint in the SELUTION SLR 014 DEB per-protocol group and 28 in the Standard of Care per-protocol group.

This endpoint is used to compare outcomes associated with the two treatment strategies over the stated follow-up. Its interpretation depends on the composite definition, the follow-up window, the analysis population, and the statistical framework. Although the trial is described as noninferiority, the margin and formal criterion for establishing noninferiority are not reported in the registry record. The observed endpoint counts alone therefore do not determine whether that objective was met.

7. Results Posted in the Registry

• SELUTION SLR 014 DEB: 16.2% (32/197) versus 14.5% (28/193) on control; risk difference 1.7 percentage points (95% CI -5.4 to 8.9), risk ratio 1.12 (0.70–1.79); unadjusted two-proportion z-test p = 0.635.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is binary at the participant level: target lesion failure occurred or did not occur within the specified follow-up. For this kind of outcome, analysis can compare the proportion of participants meeting the endpoint in each group. The registry posts participant counts, group sizes, a risk-difference estimate, a relative-risk estimate, an odds-ratio estimate, confidence intervals, and an unadjusted p-value. These measures express the same broad comparison in different statistical ways; their scales and interpretations are not interchangeable.

What does a risk difference describe?

In general, a risk difference is the event proportion in one group minus the event proportion in the comparison group. It is an absolute contrast, so its scale expresses the difference in event risk rather than a ratio. The posted risk-difference estimate is 0.017, and its confidence interval ranges from -0.054 to 0.089. Because the interval includes zero and extends to either side, it is compatible with uncertainty about both the direction and size of the group difference. This is an unadjusted comparison in the registry record.

How do relative risk and odds ratio differ?

In general, relative risk compares event probabilities as a ratio. An odds ratio compares the odds of the event between groups. Both are relative measures, but they use different quantities and can have different numerical values. The posted relative-risk estimate is 1.12, with a confidence interval from 0.702 to 1.786. The posted odds-ratio estimate is 1.143, with a confidence interval from 0.659 to 1.983. For either measure, a value of one represents no relative difference. Both reported intervals include one, so they do not isolate a single direction of effect at the confidence level used for those intervals. The confidence level itself is not reported in the registry record.

What does the p-value contribute?

The unadjusted p-value is 0.635. In general, a p-value is calculated under a null hypothesis and model assumptions. It describes the compatibility of the observed data, or more extreme data, with that null model. It is not a probability that the null hypothesis is true, nor does it show the probability that the treatments are equivalent. The word unadjusted indicates that the posted value is not presented as adjusted for multiple comparisons. The specific test and its assumptions are not reported in the registry record.

Why does the analysis population matter?

The primary endpoint is reported for a per-protocol population of 197 participants in the SELUTION group and 193 in the Standard of Care group. A per-protocol analysis is generally focused on participants considered to have followed the trial protocol sufficiently for that analysis. The registry does not report the operational criteria for inclusion in this population, the reasons participants were excluded, or how protocol deviations were handled. It also does not post an intention-to-treat estimate for the primary endpoint. As a result, readers cannot compare the posted per-protocol result with another analysis population using the registry information alone.

The adverse-event denominators differ from the primary endpoint denominators: the record lists 210 participants at risk in the SELUTION safety group and 208 in the Standard of Care safety group. Outcomes and analyses should be interpreted using their own stated populations and denominators. A safety population count should not be substituted for the primary per-protocol denominator.

What cannot be inferred from the posted analyses?

The registry identifies the trial as noninferiority, but the margin, confidence level for the noninferiority decision, detailed model, and formal decision rule are not reported in the registry record. The registry also does not report adjustment methods, covariates, or details of missing-data handling for this primary comparison. In general, the choice of model and analysis population can affect estimates and uncertainty, so those details are important for a complete methodological assessment.

The endpoint is composite, combining cardiac death, target-vessel MI, and clinically driven target lesion revascularization. In general, a composite can summarize several types of event, but the aggregate result does not reveal the contribution of each component. Component-specific primary results are not reported in the registry record. The registry lists secondary outcomes, but their detailed analysis results and any multiplicity procedure are not reported in the registry record. Those omissions limit how far the primary comparison can be used to describe the broader set of outcomes or the trial's full statistical plan.

10. Confidence Intervals and Precision

The confidence interval for the posted risk difference runs from -0.054 to 0.089 around an estimate of 0.017. It includes zero, so the data are compatible with no group difference on the risk-difference scale, as well as with values on either side of zero. The interval is also wide enough to include a range of possible differences. The posted result therefore has substantial uncertainty about both the direction and size of the contrast.

For the relative-risk estimate of 1.12, the confidence interval is 0.702 to 1.786. For the odds-ratio estimate of 1.143, it is 0.659 to 1.983. In general, a confidence interval describes a range of estimates compatible with the data under a statistical procedure and its assumptions. It is not a guarantee that the true effect lies within the particular interval, and it is not a range of individual participant outcomes. The confidence level and construction method are not reported in the registry record.

The risk-difference interval includes the null value of zero, while the relative-risk and odds-ratio intervals include the null value of one. The unadjusted p-value is 0.635. These features indicate that the registry's posted comparisons do not precisely establish a single direction of effect. They also do not establish equivalence or noninferiority: those conclusions require the trial's prespecified margin and decision rule, which are not reported in the registry record.

Precision should also be considered alongside the per-protocol analysis population. The estimates use 197 participants in the SELUTION group and 193 in the Standard of Care group, not the safety denominators. No adjusted primary estimate, alternative analysis population result, or component-specific endpoint estimate is reported in the registry record. These limits affect how completely the uncertainty around the full trial question can be assessed.

11. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not the trial's original design calculation. They give participants per arm for 80% power and participants per arm for 90% power, rather than total events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Each scenario uses the stated fraction of the observed effect as the effect to detect.

For planning based on 100% of the observed effect, the display gives 6,778 participants per arm for 80% power and 9,073 participants per arm for 90% power. For planning at 75% of the observed effect, it gives 11,910 participants per arm for 80% power and 15,944 participants per arm for 90% power. For planning at 50% of the observed effect, it gives 26,483 participants per arm for 80% power and 35,452 participants per arm for 90% power.

In plain language, 80% power means that, under the planning assumptions and if the effect used for the calculation were the true effect, the design would have an 80% chance of detecting an effect at the specified significance level. The 90% column describes the corresponding chance as 90%. Higher target power generally requires more participants for the same effect assumption. Smaller effects need more participants because they are harder to distinguish from random variation.

The planning exercise uses the observed effect as its reference, so these figures are illustrative rather than a reconstruction of the trial's own planning process. The original sample-size justification, planned power, and original effect assumptions are not reported in the registry record. This is not observed power.

12. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.145; treatment proportion p₁ = 0.162; average p̄ = 0.154.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.5101 = 0.9998.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.5100 = 0.4292.
4. n = (0.9998 + 0.4292)² / (0.0174)² = 6,777.2, rounded up to 6,778 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.145077720207254                          # control proportion
p1 <- 0.16243654822335                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(4280029)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 6,778 (80% power), 9,073 (90% power)
 75% of observed effect: n per arm = 11,910 (80% power), 15,944 (90% power)
 50% of observed effect: n per arm = 26,483 (80% power), 35,452 (90% power)
power.prop.test: 6777.2 
Simulated power at n = 6,778 per arm: 0.797 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

13. Multiplicity, Missing Data and Analysis Populations

The primary endpoint is target lesion failure at 12 months, and the posted primary comparison is unadjusted. The registry lists secondary outcomes including device, lesion, and procedure success; safety outcomes; target-vessel revascularization; target lesion failure; target vessel failure; and net adverse clinical events. When a study assesses multiple outcomes or comparisons, the chance of at least one apparently notable result can rise unless the analysis plan accounts for multiplicity. In general, a multiplicity procedure may control that risk, but the registry does not report whether one was planned or used for the outcomes.

The registry does not report a multiplicity adjustment for the posted p-value. It also does not report a complete statistical analysis plan, the sequence or hierarchy of endpoint testing, or detailed results for each secondary outcome. The posted primary p-value is explicitly unadjusted, so it should not be taken as evidence that the broader family of trial outcomes was evaluated with an error-rate adjustment.

Missing-data handling is not reported in the registry record. The record does not specify how missing 12-month outcome information was handled, whether imputation was used, or what assumptions were applied to incomplete follow-up. Reasons for missing outcome data and sensitivity analyses are also not reported. In general, missingness can affect both the estimated event proportions and the uncertainty around a comparison, depending on its extent and pattern.

The primary endpoint population is per protocol, with 197 participants in the SELUTION group and 193 in the Standard of Care group. The registry does not provide the detailed inclusion rules for that population or a posted intention-to-treat primary analysis. Without these details, it is not possible to assess how exclusions and protocol deviations may have influenced the estimate, or to compare conclusions across analysis populations.

The registry identifies the study as noninferiority, but the margin and the formal testing procedure are not reported in the registry record. These are central to interpreting a noninferiority claim. The posted counts, confidence intervals, and unadjusted p-value should therefore be considered alongside these unreported analysis details, rather than as a substitute for them.

14. 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: angina pectoris (8.2%), acute myocardial infarction (7.1%), angina unstable (3.8%), atrial fibrillation (3.8%), chest pain (3.4%).

The registry lists 210 participants at risk for serious adverse events in the SELUTION SLR 014 DEB group and 208 in the Standard of Care group. It records 78 participants affected in the SELUTION group and 91 in the Standard of Care group. For other adverse events, the record lists 27 affected participants among 210 at risk in the SELUTION group and 23 among 208 at risk in the Standard of Care group. Deaths are listed as 9 and 5, respectively.

These are safety summaries, with denominators that differ from the per-protocol populations used for the primary endpoint. They should be read as reported counts and not combined with the primary endpoint counts. The registry also lists serious adverse-event terms, including angina pectoris at 8.2%, acute myocardial infarction at 7.1%, unstable angina at 3.8%, atrial fibrillation at 3.8%, chest pain at 3.4%, and coronary artery arteriosclerosis at 2.4%.

The record does not report further detail about event timing, recurrence, severity grading, causal attribution, or statistical comparisons between groups. Counts alone do not establish whether an event was caused by a treatment, and differences in counts should not be interpreted as adjusted safety effects.

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

The posted data describe target lesion failure counts and unadjusted comparisons at 12 months in the per-protocol population. There were 32 participants with the composite endpoint in the SELUTION SLR 014 DEB group and 28 in the Standard of Care group. The risk-difference interval includes zero, and the relative-risk and odds-ratio intervals include their respective null values. The unadjusted p-value is 0.635. Together, these results leave uncertainty about the direction and size of the difference.

The record calls the study a noninferiority trial, but the posted comparison is not enough on its own to establish noninferiority. That requires a specified margin and a decision rule; neither is reported in the registry record. A non-significant result is not the same as evidence that treatments are equivalent, and the observed counts do not show that any treatment works or does not work.

The composite endpoint combines cardiac death, target-vessel myocardial infarction, and clinically driven target lesion revascularization. The total count does not reveal how many events came from each component. Component-specific primary results are not reported in the registry record. Nor does this one endpoint summarize every secondary outcome or safety result listed for the trial.

Interpretation is also limited by the per-protocol analysis population and the absence of reported details on missing data, protocol deviations, multiplicity, and the formal analysis method. The adverse-event summaries use separate safety denominators and should be interpreted on their own terms. The registry record can support a description of the posted outcomes and their statistical uncertainty, but it does not supply all information needed to evaluate the trial's full inferential plan or reach a definitive noninferiority conclusion.

16. Why This Trial Matters Statistically

This trial is statistically interesting because it compares a drug-eluting balloon strategy with a Standard of Care group that can include different procedures. The brief summary permits contemporary zotarolimus-eluting or everolimus-eluting stents and balloon angioplasty, with balloon angioplasty limited to a maximum of 20% of participants randomized to Standard of Care. The comparator is therefore a care strategy rather than a single uniform device. In general, variation within a comparator group can affect how broadly a group-level result applies to any one component of that strategy.

The trial also frames its question as noninferiority. That design objective is not assessed simply by observing similar-looking event counts or a p-value that does not reject a null hypothesis. A noninferiority interpretation depends on the prespecified margin and the confidence interval relative to that margin. Because the margin and formal decision rule are not reported in the registry record, readers cannot verify the noninferiority criterion from the posted summary alone.

The primary endpoint is a composite that includes cardiac death, target-vessel MI, and clinically driven target lesion revascularization. Composite outcomes can capture several kinds of event in one measure, but they can conceal differences in the frequency or importance of individual components. The registry's aggregate result does not show which components drove the observed endpoint counts.

Finally, the posted result uses a per-protocol population, while the safety summaries use other denominators. The distinction illustrates why a trial result needs to be read with its analysis population and outcome-specific denominator in view. The posted confidence intervals also convey that the comparison remains uncertain rather than resolving the direction of effect.

17. 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 result is reported for the per-protocol population, but the detailed eligibility rules for that analysis and the reasons participants were not included are not reported in the registry record. An intention-to-treat primary estimate is not reported. This limits comparison between analysis populations and makes it difficult to assess the effect of protocol deviations on the result.

The registry does not report the noninferiority margin, original sample-size justification, or formal statistical decision rule. It also does not report the method used to calculate the posted confidence intervals or the unadjusted p-value. These omissions prevent a full audit of whether the analysis was aligned with the trial's stated noninferiority objective.

Handling of missing endpoint data is not reported in the registry record. Neither the amount and pattern of missing primary outcome data nor any imputation or sensitivity analysis is described. The registry also does not report whether multiplicity was addressed across primary and secondary outcomes. These gaps constrain interpretation of the uncertainty and of the broader outcome set.

The primary endpoint combines three event types, but component-specific counts are not reported. The Standard of Care arm may include different interventions, and the results do not provide the comparator procedure distribution. The record does not report which parties were masked, nor additional detail on outcome adjudication. Each of these details could help readers assess the context and potential sources of variation in the comparison.

Lastly, the registry status is active, not recruiting, and its primary completion date is 2025-08-15. The registry record does not state whether further results or analyses will be posted. The limitations above concern the information reported in the registry and do not determine what may be available in other sources.

18. Related Tutorials

19. Related Statistical Calculators

20. Sources

• ClinicalTrials.gov: SELUTION SLR™ 014 In-stent Restenosis — NCT04280029.
• Registry record last updated 2026-10-20; status last verified 2026-09.
• Results first posted 2026-10-20.
• 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.

21. Record Summary

The registry identifies NCT04280029 as SELUTION SLR 014 In-stent Restenosis, sponsored by M.A. Med Alliance S.A. It is listed as a prospective, randomized, single-blind, multicenter, parallel-group study with an enrollment of 418 and status active, not recruiting. The recorded start date is 2020-07-06, and the primary completion date is 2025-08-15.

The primary outcome is the number of participants with target lesion failure at 12 months after the index procedure. The per-protocol analysis includes 197 participants in the SELUTION SLR 014 DEB group and 193 in the Standard of Care group, with 32 and 28 endpoint participants, respectively. The posted risk-difference estimate is 0.017, with an interval from -0.054 to 0.089, and the unadjusted p-value is 0.635.

The trial is described as noninferiority, but its margin and formal decision rule are not reported in the registry record. The posted result therefore supports a description of the observed comparison and its uncertainty, not a standalone conclusion about noninferiority.