Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions

NCT ID: NCT06822712

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2026-06-30

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

Conditions

Coronary Arterial Disease (CAD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test Group

Sirolimus-coated Coronary Balloon Dilatation Catheter

Group Type: EXPERIMENTAL

Sirolimus-coated Balloon Dilatation Catheter

Intervention Type: DEVICE

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

Control Group

Paclitaxel-coated Balloon Catheter (Brand: Bingo®)

Group Type: ACTIVE_COMPARATOR

Paclitaxel-coated Balloon Dilatation Catheter

Intervention Type: DEVICE

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

Interventions

Sirolimus-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

Intervention Type: DEVICE

Paclitaxel-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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Participants in this clinical trial must meet all of the following 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.

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:

1. Unstable Arrhythmias: Such as high-risk ventricular premature beats or ventricular tachycardia.

2. Severe Heart Failure (New York Heart Association Functional Classification, NYHA Class IV).

3. Preoperative Renal Impairment: Or currently undergoing hemodialysis treatment.

4. Bleeding Tendencies or Contraindications to Antiplatelet Agents and Anticoagulants: Participants who cannot undergo antithrombotic therapy.

5. History of Peptic Ulcer or Gastrointestinal Bleeding within the Past 6 Months: Or history of cerebral hemorrhage, cerebral infarction, or other cerebrovascular accidents (stroke) within the past 6 months.

6. Known Allergies to Contrast Agents, Paclitaxel, Sirolimus, or Their Derivatives.

7. Life Expectancy Less Than 12 Months.

8. Poor Compliance: Participants who, in the investigator's judgment, are unlikely to adhere to the study requirements or are otherwise deemed unsuitable for inclusion.

9. Participation in Other Ongoing Clinical Trials: Participants who have not reached the primary endpoint in other ongoing clinical trials.

10. Pregnant or Lactating Women: Women who plan to conceive within 12 months or are unwilling to use effective contraception.

1. Left Main Trunk and Its Bifurcation Lesions Requiring Treatment.

2. Thrombus in the Target Lesion: Excessive tortuosity of the vessel, making it unlikely for the balloon to pass through the lesion.

3. Total Occlusion in the Side Branch Lesion of the Target Lesion.

4. Severe Calcification in the Side Branch Lesion of the Target Lesion: Lesions that cannot be pre-dilated or treated with double-balloon kissing dilation.

5. In-Stent Restenosis in the Target Vessel (Including Both Main and Side Branches).

6. Residual Stenosis >30% (by Visual Estimation) or Dissection Grade C or Higher After Pre-Dilation or Double-Balloon Kissing Dilation of the Side Branch Lesion of the Target Lesion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Lanzhou University

UNKNOWN

Sponsor Role: collaborator

BrosMed Medical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Bai Ming

Role: primary

baiming@vip.163.com

0931-8619797

Other Identifiers

BM-D19-2

Identifier Type: -

Identifier Source: org_study_id