Using sirolimus drug-eluting balloons to treat coronary bifurcation lesions

A Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Trial to Evaluate the Efficacy and Safety of Sirolimus Drug-eluting Coronary Balloon Catheter in Treatment of Coronary Bifurcation Lesions

This study is testing if a new type of balloon treatment using sirolimus can help people with specific heart artery blockages just as well as the current treatment with paclitaxel balloons.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT04896177 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of sirolimus drug-eluting coronary balloon catheters in treating coronary bifurcation lesions. It is a prospective, multicenter, randomized controlled trial involving 280 participants who will undergo percutaneous coronary intervention (PCI) with either sirolimus or paclitaxel drug-eluting balloons. Participants will be followed for up to 24 months to assess outcomes. The study aims to determine if sirolimus DEB is non-inferior to paclitaxel DEB in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with evidence of myocardial ischemia and specific angiographic findings related to bifurcation lesions.

Not a fit: Patients with pregnant or lactating women will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with coronary bifurcation lesions.

How similar studies have performed: Other studies have shown success with drug-eluting balloons in coronary interventions, but the specific use of sirolimus in bifurcation lesions is less established.

Eligibility criteria

Inclusion Criteria:

1. Male or Female that ages 18-85 year old;
2. Having evidence of myocardial ischemia;
3. Voluntarily participates in this study and signs the informed consent form (ICF);
4. Sufficiently compliant with the study protocol and agreed to receive follow-up at 1 month ±7 days, 6 months ±14 days, 9 months ±30 days, 12 months ±30 days, and 24 months ±30 days, of which angiography was required at 9 months ±30 days;
5. Angiography confirmed as de novo bifurcation lesion with side-branch stenosis (diameter) ≥70%;
6. Suitable for PCI and side-branch lesions are not expected to stent implantation, and no drug-eluting balloon used for the main-branch. If a stent is implanted into the main-branch, it's usually necessary to perform a final balloon kissing on the two branches;
7. Residual stenosis of the side-branch lesion ≦50% after pre-treatment, with a TIMI flow grade 3;
8. The target vessel diameter was 2.0mm-4.0mm.

Exclusion Criteria:

1. Women who is pregnant or lactating, or having a fertility plan within 1 year or are unwilling to take effective contraceptive measures;
2. Cardiogenic shock patients;
3. With hemorrhagic symptoms or active gastrointestinal ulcers, or previous stroke within 6 months, or who are expected to be unable to tolerate double-antibody therapy after interventional therapy;
4. ST-segment elevation myocardial infarction (STEMI) occurred within one week before enrollment;
5. With severe congestive heart failure or NYHA class Ⅳ heart failure;
6. With severe valvuar heart disease;
7. Heart transplant patients;
8. With renal insufficiency (creatinine \> 3.0mg/ dL or 265.2 umol /L) and/or advanced renal disease requiring dialysis;
9. With a life expectancy less than 1 year;
10. With contraindications who cannot take aspirin and/or clopidogrel and/or ticagrelor;
11. With known allergies to paclitaxel, sirolimus, contrast agents, etc.;
12. Participating in clinical trials of other drugs or devices and has not met the primary endpoint;
13. Non-target lesions cannot be processed before the target lesions or non-target lesions treatment fails;
14. Intra-stent restenosis;
15. High-risk left main disease;
16. Other patients considered by the investigator to be unsuitable for inclusion.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wei Huang, Dr.

Conditions Coronary Bifurcation Lesions; drug-eluting balloon; coronary bifurcation lesions; coronary heart disease; sirolimus