Sirolimus-coated versus paclitaxel-coated balloon treatment for new coronary bifurcation blockages

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

This trial tests whether a sirolimus-coated balloon works better and is as safe as a paclitaxel-coated balloon for adults aged 18–80 with new (de novo) coronary bifurcation blockages.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: BrosMed Medical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Lanzhou, Gansu)
• Trial ID: NCT06822712 on ClinicalTrials.gov

What this trial studies

Adults with de novo coronary bifurcation lesions who are candidates for coronary revascularization will receive balloon dilatation with either a sirolimus-coated or a paclitaxel-coated coronary balloon catheter. The trial compares safety and effectiveness between the two coated balloons, with invasive imaging follow-up required to document vessel outcomes. Enrollment is limited to people meeting angiographic criteria (maximum two treated vessels and up to three lesions total) and who can provide informed consent. Key outcomes will include device-related adverse events and measures of vessel patency or need for repeat revascularization.

Who should consider this trial

Good fit: Adults aged 18–80 with symptomatic or ischemic coronary artery disease involving de novo bifurcation lesions who are suitable for coronary revascularization and willing to undergo invasive imaging follow-up are ideal candidates.

Not a fit: Patients older than 80, those with very recent myocardial infarction (within 7 days), unsuitable for revascularization, or with more extensive multivessel disease beyond the angiographic limits are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could reduce restenosis and the need for repeat procedures after treating bifurcation lesions.

How similar studies have performed: Paclitaxel-coated balloons have established clinical use with mixed results in various coronary settings, while sirolimus-coated balloons are a newer technology with promising early data but limited large randomized evidence.

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.

Where this trial is running

Lanzhou, Gansu

• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Recruiting)

Conditions Coronary Arterial Disease