Coronary Arterial Disease (CAD)
Conditions
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
Interventions
DEVICESirolimus-coated Balloon Dilatation Catheter
During 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
DEVICEPaclitaxel-coated Balloon Dilatation Catheter
During 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
Sponsors
First Affiliated Hospital of Lanzhou University
BrosMed Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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. Successful interventional treatment of the non-target lesion prior to the target lesion. 4. Only one true bifurcation lesion requiring treatment (Medina classification 1.1.1, 1.0.1, 0.1.1), with a diameter stenosis ≥70% (by visual estimation) at the ostium of the target lesion side branch. 5. Successful pre-dilation/kissing balloon of the target lesion side branch, no dissection grade C or higher, residual stenosis ≤30% (by visual estimation) in the side branch lesion, and TIMI 3 flow. 6. Suitable for PCI, with the main branch lesion of the target lesion planned for stent implantation without drug-coated balloon treatment, and the side branch lesion treated with a drug-coated balloon without stent implantation; it is recommended to perform kissing balloon dilation for both the main and side branches. 7. Reference diameter of the target lesion side branch 2.0-4.0 mm, and lesion length ≤38 mm.
Exclusion criteria
If a participant has any of the following conditions, they will be excluded from the study: General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of stenosis | 9 Months postoperatively | Degree of stenosis (%) of target bifurcation lesion segment diameter at 9 months postoperatively (Measured by QCA) |
Countries
China
Outcome results
None listed