This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease (NCT05509296), a randomized na study. The primary outcome is Number of Device Procedural Success(Lesions Level).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05509296 |
| Phase | NA |
| Condition | Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 136 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Sino Medical Sciences Technology Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with stenotic coronary arteries undergoing percutaneous coronary intervention were enrolled. The listed conditions include coronary stenosis, coronary artery stenosis, and in-stent restenosis. The primary endpoint is defined at the lesion level, while several secondary outcomes concern participants.
Intervention
The intervention was SINOMED CBC, described as a cutting balloon catheter. The study objective was to evaluate its safety and effectiveness during coronary intervention in people with stenotic coronary arteries.
Comparator
The comparison group received an NSE Coronary Dilatation Catheter. The record identifies it as a device from Goodman Co.,Ltd. The registry describes the study as randomized, parallel-group, and unmasked.
Primary question
The primary outcome was the number of lesions meeting the registry’s definition of device procedural success immediately after intervention, at approximately 1.4 hour. The title describes a non-inferiority investigation, but the non-inferiority margin and a primary-endpoint comparison are not reported in the registry record.
3. Trial Design
The registry describes a prospective, multicenter, randomized, parallel-group, unmasked device study. It lists an enrollment of 136 and a completed status. The study began on 2022-09-20, and primary completion is recorded as 2022-11-23. The phase is listed as NA. Sino Medical Sciences Technology Inc. is identified as the sponsor.
The two intervention groups were SINOMED CBC and the NSE Coronary Dilatation Catheter. The record identifies SINOMED CBC as a cutting balloon catheter and describes the comparator as an NSE Coronary Dilatation Catheter. Masking is listed as none, so the design was not blinded according to the registry entry. Allocation is listed as randomized, but details of sequence generation, allocation concealment, or implementation are not reported in the registry record.
The primary outcome was a lesion-level count of device procedural successes, with an immediate post-intervention timeframe of approximately 1.4 hour. Other listed outcomes include participant-level procedural success, target lesion failure, a patient-oriented composite endpoint, adverse events, device defects, and serious adverse events. The registry gives further results for participant-level procedural success and safety, but results for several other listed outcomes are not reported in the registry record.
The title identifies the study as a non-inferiority investigation. However, the prespecified margin, the sample-size justification, the analysis population definitions, and the statistical plan are not reported in the registry record. The registry record also does not report interim analyses. These omissions limit how fully the design and analysis can be evaluated from the posted information.
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
| Stage | SINOMED CBC | NSE Coronary Dilatation Catheter |
|---|---|---|
| STARTED | 67 | 69 |
| COMPLETED | 66 | 68 |
| NOT COMPLETED | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: lesions
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 Full Analysis Set (FAS) comprised 66 subjects in the experimental group and 68 subjects in the control group. One subject randomized to the experimental group was excluded from the analysis due to withdrawal of consent prior to receiving the experimental balloon. One subject randomized to the control group was excluded for meeting exclusion criterion 1 and did not receive the control balloon.
| Characteristic | Unit | SINOMED CBC | NSE Coronary Dilatation Catheter | Total |
|---|---|---|---|---|
| Participants analysed | 66 | 68 | 134 | |
| Age, Continuous | years | 62.44 (SD 8.27) | 63.72 (SD 8.16) | 63.09 (SD 8.21) |
| Sex: Female, Male: Female | Participants | 19 | 22 | 41 |
| Sex: Female, Male: Male | Participants | 47 | 46 | 93 |
| Race/Ethnicity, Customized: China | Participants | 66 | 68 | 134 |
| Number of target lesions: 1 Lesion | Participants | 63 | 65 | 128 |
| Number of target lesions: 2 Leisons | Participants | 3 | 3 | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Device Procedural Success(Lesions Level), measured over immediate post-intervention(approximately 1.4 hour).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | lesions |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of lesions with device procedural success, assessed immediately after intervention, at approximately 1.4 hour. The registry defines success using both device-delivery criteria and the final angiographic stenosis criterion. Successful delivery requires delivery, inflation, deflation, and withdrawal of the study balloon. The definition also requires final diameter stenosis of ≤30% after the interventional procedure, including adjunctive stenting. For in-stent restenosis or drug-coated-balloon-related stenosis, the stated threshold is final diameter stenosis <50%.
In general, a procedural-success endpoint combines whether the device could be used as intended with a technical result after the procedure. Such an endpoint can describe immediate procedural performance, but it does not by itself describe longer-term outcomes. The registry’s timeframe is immediate, so the primary measure does not establish what happened after the procedure.
The record reports 68 successful lesions for SINOMED CBC and 68 for the NSE catheter. These are counts, not reported percentages. The primary outcome is at the lesion level, while the group enrollment counts refer to participants. A lesion denominator for each group, and a statistical comparison of the primary counts, are not reported in the registry record. Therefore, the posted counts alone do not establish the proportion of lesions meeting the definition or the uncertainty around a between-group difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary endpoint results are posted as 68 successful lesions in the SINOMED CBC group and 68 in the NSE catheter group. Because the endpoint is a lesion-level count and no lesion denominators or statistical comparison are reported in the registry record, these equal counts should not be read as proof that the groups had equal success proportions. They also do not establish non-inferiority. Although the study title describes a non-inferiority investigation, the margin and the primary-endpoint analysis are not reported in the registry record.
The available comparative estimate concerns participant-level procedural success, a secondary outcome rather than the lesion-level primary endpoint. The posted risk difference for NSE compared with SINOMED CBC is -0.029, with a 95% confidence interval from -0.086 to 0.028 and p = 0.325. The interval includes zero, so the posted estimate is compatible with differences in either direction as well as no difference. Its span indicates uncertainty around the estimate; the result does not by itself establish equivalence or non-inferiority. The registry does not report an adjusted analysis for this comparison.
The registry also posts a risk ratio of 0.971, with a confidence interval from 0.915 to 1.03, and an odds ratio of 0.333, with a confidence interval from 0.034 to 3.289. These measures are based on the same participant-level outcome and are not independent confirmations. Their confidence intervals are broad, particularly for the odds ratio, and indicate that the estimated association is imprecise. The unadjusted p-value is 0.325. No reported analysis specifies covariate adjustment or a different estimand.
Counts for participant-level procedural success are 65 in each group, with group sizes of 66 and 68. The posted comparison gives event proportions of 0.985 for SINOMED CBC and 0.956 for NSE. The comparison is a secondary result and should not replace the primary lesion-level question. In particular, a participant-level success count and a lesion-level procedural count address different units of analysis.
The registry’s planning illustration uses the observed participant-level effect under stated assumptions. Such sample sizes are hypothetical planning quantities, not evidence of the trial’s actual design rationale and not observed power. The registry does not report a sample-size justification for the trial. The posted information supports a cautious reading: participant-level procedural success was common in both groups, but the comparative estimate remains uncertain, and the primary outcome lacks a reported between-group analysis.
9. Statistical Methods Explained
Interpretation depends on matching each result to its outcome definition, analysis unit, and timeframe. The primary measure counts lesions and concerns immediate technical success. Participant-level procedural success is a separate secondary outcome. A lesion count cannot be substituted for a participant count, and the two endpoints need not answer the same question. The registry does not report a lesion denominator or a comparison for the primary outcome, so a primary-effect estimate cannot be recovered from the posted counts alone.
What does a risk difference describe?
In general, a risk difference expresses the difference between the event proportions in two groups. The posted risk difference of -0.029 compares NSE with SINOMED CBC for participant-level procedural success. A negative value indicates that the estimated proportion is lower in the NSE group under this comparison’s stated ordering. The confidence interval, from -0.086 to 0.028, describes a range of values compatible with the data under the method’s assumptions. Because the interval includes zero, it does not rule out no difference. It also includes values on both sides of zero, so it does not determine the direction with precision.
A confidence interval is not a guarantee that the true effect lies in the displayed range. In general, it summarizes sampling uncertainty for an estimate under a statistical model and a specified procedure. Its interpretation depends on whether the outcome, group assignment, and analysis method are appropriate. The registry posts the estimate and interval but does not report a detailed analysis plan, so the underlying analysis choices cannot be fully assessed from the record.
How should the p-value be read?
The unadjusted p-value for participant-level procedural success is 0.325. In general, a p-value measures how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the statistical assumptions held. It is not the probability that the null hypothesis is true, and it is not a measure of clinical importance. This p-value does not establish equivalence or non-inferiority. Those conclusions require a defined margin and an analysis aligned with the non-inferiority question; the margin and primary analysis are not reported in the registry record.
The term unadjusted indicates that the posted p-value is not presented as adjusted for multiple testing. The record lists several secondary outcomes, but does not report a multiplicity plan. When many outcomes or comparisons are examined, the chance of at least one apparently notable result can increase. Without a prespecified testing hierarchy or adjustment strategy, secondary p-values should be treated as exploratory rather than as a collection of independent confirmatory tests.
Why do risk ratios and odds ratios differ?
In general, the risk ratio compares event proportions directly, whereas the odds ratio compares event odds. These are distinct effect measures and can differ in magnitude, especially when an event is common. For this outcome, the registry posts a risk ratio of 0.971 with a confidence interval from 0.915 to 1.03, and an odds ratio of 0.333 with a confidence interval from 0.034 to 3.289. The broad odds-ratio interval conveys substantial uncertainty. Neither measure is a separate trial finding from the risk difference; each summarizes the same underlying comparison using a different scale.
What does the planning illustration represent?
In general, a sample-size calculation estimates how many participants may be needed under assumptions about the effect to detect, allocation, significance level, and statistical method. The registry states that its planning illustration uses the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. It includes scenarios based on 100%, 75%, and 50% of the observed effect, with estimates for 80% and 90% power.
These values are planning illustrations rather than the actual enrollment rationale. They do not show that the trial had the stated power, and they are not observed power calculations. The observed effect is itself uncertain, so using it as a planning input is not equivalent to choosing a clinically justified target difference. The registry does not report the trial’s own sample-size justification or confirm that these assumptions were used when the study was designed.
In general, over-dispersion occurs when count variability exceeds what a simple model assumes. It can make standard errors too small if not accounted for, weakening the reliability of interval estimates and tests. No dispersion estimate is posted for the primary count outcome, and the registry reports no analysis for it. The available information is therefore insufficient to assess a count-model choice or whether over-dispersion was considered.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint and several secondary outcomes, but the statistical plan is not reported in the registry record. In particular, the record does not report how many hypotheses were intended to be tested formally, whether secondary outcomes were prespecified as confirmatory or exploratory, or whether a testing hierarchy or multiplicity adjustment was planned. It also does not report interim analyses. These omissions matter because repeated testing can increase the chance of at least one apparently unusual result even when there is no underlying effect.
The posted p-value for participant-level procedural success is identified as unadjusted. Without a documented multiplicity strategy, it should not be treated as though it controls the overall error rate across all outcomes. This does not invalidate a descriptive estimate, but it limits the strength of a confirmatory interpretation. The record does not provide a reported analysis for the primary endpoint, so the central non-inferiority question cannot be assessed through a posted primary hypothesis test.
Missing-data methods and analysis populations are also not reported in the registry record. The available entries give group sizes and event counts for some outcomes, but do not explain how participants with incomplete follow-up, missing measurements, protocol deviations, or other analysis issues were handled. The record does not identify an intention-to-treat, per-protocol, or other analysis population for the posted comparisons. These details are especially relevant to non-inferiority investigations, where the analysis population and handling of missing information can affect interpretation.
The registry provides no information about whether imputation, complete-case analysis, or another approach was used, and it does not report sensitivity analyses. It is therefore not possible to assess whether missing observations could have changed the estimates. The absence of these details should be understood as a reporting limitation rather than evidence that data were missing or that a particular method was used.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| SINOMED CBC | 1 | 66 | 1.5% |
| NSE Coronary Dilatation Catheter | 1 | 68 | 1.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| SINOMED CBC | 0 of 66 |
| NSE Coronary Dilatation Catheter | 0 of 68 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| SINOMED CBC | 21 of 66 |
| NSE Coronary Dilatation Catheter | 18 of 68 |
Most frequent serious adverse event terms
| Event term | Organ system | SINOMED CBC | NSE Coronary Dilatation Catheter |
|---|---|---|---|
| Cerebral infarction | Nervous system disorders | 0 of 66 | 1 of 68 |
| Mesenteric arteriosclerosis | Vascular disorders | 1 of 66 | 0 of 68 |
Most frequent non-serious adverse event terms
| Event term | Organ system | SINOMED CBC | NSE Coronary Dilatation Catheter |
|---|---|---|---|
| Myocardial injury | Cardiac disorders | 6 of 66 | 5 of 68 |
| Hypokalaemia | Metabolism and nutrition disorders | 3 of 66 | 2 of 68 |
| Hyperlipemia | Metabolism and nutrition disorders | 1 of 66 | 1 of 68 |
| Hypertriglyceridemia | Metabolism and nutrition disorders | 1 of 66 | 1 of 68 |
| Vomiting | Gastrointestinal disorders | 0 of 66 | 2 of 68 |
| Gingival hemorrhage | Gastrointestinal disorders | 0 of 66 | 2 of 68 |
| Insomnia | Psychiatric disorders | 2 of 66 | 0 of 68 |
| Upper respiratory tract infection | Infections and infestations | 2 of 66 | 0 of 68 |
| Rash | Skin and subcutaneous tissue disorders | 1 of 66 | 1 of 68 |
| Anemia | Blood and lymphatic system disorders | 2 of 66 | 0 of 68 |
Serious events with the highest arm-level rate: mesenteric arteriosclerosis (1.5%), cerebral infarction (1.5%).
The registry reports serious adverse events in 1 participant in the SINOMED CBC group and 1 participant in the NSE catheter group. The corresponding groups at risk are 66 and 68. No deaths are reported in either group. The record also reports other adverse events affecting 21 participants in the SINOMED CBC group and 18 in the NSE group. These are counts; the registry does not provide a comparative statistical analysis for these safety figures.
The listed serious-event terms are mesenteric arteriosclerosis and cerebral infarction, each reported at 1.5%. The record does not make clear from these entries whether the terms represent all serious events, how event timing was assessed, or whether investigators judged events related to a device or procedure. The listed adverse-event counts should therefore be read as descriptive safety information, not as estimates of a causal treatment effect.
In general, small numbers of serious events provide limited precision for comparing groups. Similar counts do not establish that risks are equal, and different counts do not by themselves establish a device-related difference. The registry does not report a formal safety comparison, confidence intervals, or a detailed safety analysis plan. These figures provide a record of reported events during the study, but cannot resolve comparative safety with precision.
12. What the Result Does, and Does Not, Mean
The posted results describe a randomized comparison of SINOMED CBC and the NSE Coronary Dilatation Catheter in a study of stenotic coronary artery disease. For the primary endpoint, the registry reports 68 successful lesions in each group. Those counts communicate the recorded number meeting the procedural-success definition, but the record does not give lesion denominators or a statistical comparison. They therefore do not establish equal success proportions, and they do not answer the non-inferiority question by themselves.
The participant-level procedural-success result offers a separate comparison. The risk-difference estimate is -0.029, with a confidence interval from -0.086 to 0.028 and an unadjusted p-value of 0.325. The interval includes zero and spans values favoring either group. This indicates uncertainty in the estimated difference; it does not prove equivalence, non-inferiority, or absence of an important difference. The registry does not report the non-inferiority margin needed to interpret this result against a non-inferiority criterion.
The results do not establish long-term effectiveness. The primary endpoint is assessed immediately after the intervention, and the record does not provide comparative results for several listed secondary outcomes. The reported safety counts are descriptive and do not provide a precise statistical comparison. Conclusions about device-related safety or later clinical outcomes would go beyond what these registry entries show.
In general, a trial result is most informative when the endpoint, analysis population, estimand, and statistical plan are clearly specified and results include estimates with uncertainty. Important elements of that context—including the primary comparison, non-inferiority margin, analysis populations, missing-data methods, and multiplicity approach—are not reported in the registry record. The posted figures should be read as a limited account of recorded outcomes rather than as a complete statistical evaluation of the study.
13. Why This Trial Matters Statistically
This trial illustrates why the unit of analysis matters. The primary outcome counts successful lesions, while enrollment and several secondary outcomes refer to participants. A count of successful lesions cannot be interpreted as a participant-level success rate without a lesion denominator, and it cannot be compared directly with a participant-level endpoint. The registry reports the primary counts but not the denominators or statistical comparison needed to quantify the primary effect.
It also illustrates the distinction between describing an outcome and testing a research claim. Equal posted counts are descriptive, but do not alone demonstrate equivalence or non-inferiority. A non-inferiority question requires a stated margin and an analysis designed to compare the estimated effect with that margin. The registry title identifies a non-inferiority investigation, while the margin and primary analysis are not reported in the registry record. This gap leaves the central statistical claim difficult to assess.
Another statistical issue is precision. The participant-level procedural-success estimate has a confidence interval that includes no difference and values in either direction. The point estimate alone cannot show how uncertain the comparison is. Reading the interval alongside the estimate helps prevent overstatement, while recognizing that no confidence interval can compensate for absent details about the analysis plan.
Finally, the record demonstrates the importance of transparent reporting across endpoints. Multiple secondary outcomes are listed, but results are not available for all of them, and multiplicity handling is not reported. Safety counts can be informative descriptively, yet small event counts offer limited precision for comparative claims. Together, these features show why estimates, denominators, prespecified methods, and complete outcome reporting are necessary for a sound interpretation of randomized clinical research.
14. 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.
A central limitation is that the registry does not report an inferential analysis for the primary lesion-level endpoint. The posted success counts lack lesion denominators, confidence intervals, and a between-group estimate. As a result, the primary comparison cannot be evaluated for precision from the record. The participant-level procedural-success comparison does not fill that gap because it is a different endpoint with a different analysis unit.
The title describes a non-inferiority study, but the non-inferiority margin is not reported in the registry record. The record also does not report the trial’s sample-size justification, protocol-level statistical plan, analysis populations, or missing-data methods. Without these details, the appropriateness of the analysis for the stated study objective cannot be assessed. There is also no reported multiplicity strategy for the several listed secondary outcomes.
Outcome reporting is incomplete in the posted entries. Although multiple secondary outcomes are listed, outcome-specific comparative results are not reported in the registry record for several of them. This restricts assessment of whether findings across procedural, clinical, and device-related measures form a consistent pattern. The available safety information is descriptive, and a formal comparative safety analysis is not reported.
The study is unmasked according to the registry. In general, lack of masking can influence behavior, outcome assessment, or reporting, although the extent depends on the outcome and trial conduct. The registry does not provide enough information to determine whether or how this affected the reported results. Likewise, details of randomization procedures and allocation concealment are not reported in the registry record. These are reporting limitations; they do not establish that a specific bias occurred.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease — NCT05509296.
- Registry record last updated 2026-03-27; status last verified 2026-03.
- Results first posted 2026-03-27.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT05509296 is a completed, prospective, multicenter, randomized, unmasked, parallel-group device study sponsored by Sino Medical Sciences Technology Inc. It compares SINOMED CBC with the NSE Coronary Dilatation Catheter in participants with stenotic coronary artery disease. Enrollment is listed as 136, with a start date of 2022-09-20 and primary completion on 2022-11-23.
The primary outcome is the number of lesions meeting the registry’s immediate procedural-success definition. The posted count is 68 in each group, but lesion denominators and a primary statistical comparison are not reported in the registry record. The secondary participant-level procedural-success comparison is imprecise, and the stated non-inferiority margin and analysis plan are not reported. Safety entries provide descriptive counts, while results for several listed secondary outcomes are absent. The record therefore supports a limited descriptive reading rather than a complete evaluation of the primary non-inferiority question.