N/A
Completed N=136
Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
Coronary Stenosis · Coronary Artery Stenosis · In-stent restenosis
Source: ClinicalTrials.gov NCT05509296 ↗
Enrolled (actual)
136
Serious AEs
1.5%
Results posted
Mar 2026
Primary outcomePrimary: Number of Device Procedural Success(Lesions Level) — 68; 68 lesions
Summary
The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Device Procedural Success(Lesions Level) |
68; 68 | — |
| SECONDARY Number of Participants With Procedural Success (Patient Level) |
65; 65 | — |
| SECONDARY Number of Participants Who Experienced Target Lesion Failure (TLF) |
0; 0 | — |
| SECONDARY Number of Participants Who Experienced Patient-oriented Composite Endpoint (POCE) |
0; 0 | — |
| SECONDARY Number of Participants With Any Adverse Events (AE) |
21; 18 | — |
| SECONDARY Number of Device Defects |
0; 0 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAE) |
1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- The patient is at least 18 to 75 years of age, male or not pregnant female.
- Evidence of myocardial ischemia without symptoms, stable or unstable angina, silent ischemia demonstrated by positive territorial functional study, or old myocardial infarction.
- De novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis.
- Reference vessel diameter (RVD) must be visually estimated ≥ 2.5 and ≤ 5.0mm, and the vessel length must be no more than 30mm.
- Target lesion(s) must have a diameter stenosis of (a) ≥70% by visual estimation or (b) >50% with evidence of ischemia.
- The patient has a planned intervention at no more than two de novo lesions, in different epicardial vessels.
- Investigators believe that target lesion atherosclerotic plaques require spinous balloon treatment and balloon can be passed through by pre-dilation.
- Able to understand the purpose of the trial, voluntarily participate and sign the informed consent.
Exclusion Criteria
- Evidence of ongoing acute myocardial infarction within a week.
- Chronic total occlusion (TIMI 0), left main lesion, intervention-required three-vessel lesions, and bypass lesion.
- Severe calcification and Target lesion in a severe angulation (> 45 degrees).
- Patient has serious heart failure symptoms (NYHA level III or IV), or Left ventricular ejection fraction (LVEF) 176.82umol/L or Cr >2.0 mg/dl.
- Patient with active gastrointestinal bleeding history, any other evidence based bleeding, such as suspected liver failure disease, suffered from cerebral bleeding history, stroke during the last 6 months, with contra-indication of anti-platelet or anti-coagulation.
- Patients with allergies to heparin and contrast media.
- Target lesion demonstrating severe dissection prior to planned deployment of the trial device.
- Visible thrombus at the target lesion.
- Patients received heart transplantation.
- Participation in another clinical trial (12 months after index procedure).
- Those who participated in another clinical trials, but did not reach the primary endpoint.
Data sourced from ClinicalTrials.gov (NCT05509296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.