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
Age ≥18 years and ≤80 years.
Evidence of asymptomatic myocardial ischemia, or stable/unstable angina, or myocardial infarction that occurred more than 7 days before enrollment and is now stable.
Suitable for any type of coronary artery revascularization, such as balloon angioplasty, stent implantation, and coronary artery bypass grafting (CABG).
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.
Unstable Arrhythmias: Such as high-risk ventricular premature beats or ventricular tachycardia.
Severe Heart Failure (New York Heart Association Functional Classification, NYHA Class IV).
Preoperative Renal Impairment: Or currently undergoing hemodialysis treatment.
Bleeding Tendencies or Contraindications to Antiplatelet Agents and Anticoagulants: Participants who cannot undergo antithrombotic therapy.
Parallel
Sirolimus-coated Balloon Dilatation Catheter
DeviceDuring PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Sirolimus-coated Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure
Paclitaxel-coated Balloon Dilatation Catheter
DeviceDuring PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Paclitaxel-coated Balloon Dilatation Catheter in the control group, subsequently completing the remaining procedure
Degree of stenosis
Degree of stenosis (%) of target bifurcation lesion segment diameter at 9 months postoperatively (Measured by QCA)
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BrosMed Medical Co., Ltd
Lead sponsor
LanZhou University
Collaborator
