NCT06822712 Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions
| NCT ID | NCT06822712 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BrosMed Medical Co., Ltd |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2026-06 |
Trial Parameters
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Brief Summary
Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated balloon catheter for the Treatment of De Novo Coronary Bifurcation Lesions
Eligibility Criteria
Inclusion Criteria: Participants in this clinical trial must meet all of the following criteria: General Inclusion Criteria 1. Age ≥18 years and ≤80 years. 2. Evidence of asymptomatic myocardial ischemia, or stable/unstable angina, or myocardial infarction that occurred more than 7 days before enrollment and is now stable. 3. Suitable for any type of coronary artery revascularization, such as balloon angioplasty, stent implantation, and coronary artery bypass grafting (CABG). 4. Capable of understanding the purpose of the trial, willing to participate, and acknowledging the risks and benefits described in the informed consent document by signing the informed consent form, and willing to undergo invasive imaging follow-up. Angiographic Inclusion Criteria 1. A maximum of 2 vessels requiring treatment, with no more than 3 lesions in total. 2. If the non-target lesion and the target lesion are in the same vessel, the non-target lesion must be located distal to the target lesion. 3. Success