A Prospective, Multicenter, Noninferiority, Randomized Controlled Clinical Trial 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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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⁃ Participants in this clinical trial must meet all of the following criteria:

• 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.

⁃ Angiographic Inclusion Criteria

• A maximum of 2 vessels requiring treatment, with no more than 3 lesions in total.

• 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.

• Successful interventional treatment of the non-target lesion prior to the target lesion.

• 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.

• 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.

• 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.

• Reference diameter of the target lesion side branch 2.0-4.0 mm, and lesion length ≤38 mm.

Locations
Other Locations
China
The First Hospital of Lanzhou University
RECRUITING
Lanzhou
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2026-06
Participants
Target number of participants: 250
Treatments
Experimental: Test Group
Sirolimus-coated Coronary Balloon Dilatation Catheter
Active_comparator: Control Group
Paclitaxel-coated Balloon Catheter (Brand: Bingo®)
Sponsors
Collaborators: First Affiliated Hospital of Lanzhou University
Leads: BrosMed Medical Co., Ltd

This content was sourced from clinicaltrials.gov