Clinical trial NCT06822712: Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Arterial Disease (CAD)
Lead sponsor: BrosMed Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: LanZhou University
First posted: 2025-02-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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 Exclusion Criteria

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.

Angiographic Exclusion Criteria

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.

Primary outcomes:
measure: Degree of stenosis
timeFrame: 9 Months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: