Using Sirolimus-Coated Balloons for Treating Coronary Bifurcation Lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective randomized controlled study evaluates the safety and effectiveness of Sirolimus-coated spiral balloons compared to Paclitaxel-coated balloons in treating coronary bifurcation lesions. The trial aims to enroll 280 patients with true coronary bifurcation lesions in native coronary arteries, who will be randomized to receive one of the two treatments. Data will be collected during the procedure and at follow-up visits, including angiography at 9 months post-procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged between 18 and 85 years, regardless of gender.
* Patients must voluntarily participate in the study and sign an informed consent form.
* Patients must demonstrate sufficient adherence to the study protocol and agree to follow-up visits at 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), and 24 months (±30 days) post-procedure, with angiography required at 9 months (±30 days).
* Patients must have evidence of myocardial ischemia.
* Angiographically confirmed primary coronary bifurcation lesions (Medina classification non-0, 0, 1) with branch stenosis ≥70% (estimated visually).
* Patients suitable for PCI where the branch lesion is not expected to require stenting; stenting is planned for the main vessel, with DCB used on the branch. It is recommended to treat the branch with DCB first, followed by main vessel stenting.
* Residual stenosis ≤50% after pre-treatment of the branch lesion, TIMI 3 flow, with no dissection or only A or B grade dissection. C grade dissections should be carefully considered by the investigator before deciding, and are generally not included.
* The diameter of the branch vessel must be between 2.0 mm and 4.0 mm, with a lesion length ≤40 mm.

Exclusion Criteria:

* Patients with bleeding disorders or active gastrointestinal ulcers, those who have had a stroke within the past 6 months, or those who are expected to be intolerant to dual antiplatelet therapy post-intervention.
* Patients with severe renal insufficiency (creatinine level \> 3.0 mg/dL or 265.2 µmol/L) and/or end-stage renal disease requiring dialysis.
* Patients in cardiogenic shock.
* Patients who have experienced a myocardial infarction within the week prior to enrollment.
* Patients with severe congestive heart failure or NYHA class IV severe heart failure.
* Patients with severe valvular heart disease.
* Patients who have undergone heart transplantation.
* Patients with a life expectancy of less than 1 year.
* Patients currently participating in other drug or device clinical trials that have not yet reached the primary endpoint.
* Patients with contraindications to taking aspirin and/or clopidogrel and/or ticagrelor.
* Patients known to be allergic to paclitaxel, rapamycin, contrast agents, etc.
* Pregnant or breastfeeding women, those with plans to conceive within the year, or those unwilling to use effective contraception.
* Target vessels that are completely occluded, severely calcified, have \>45° angulation, or are non-protected left main lesions.
* Non-target lesions that cannot be treated prior to or fail to be treated successfully before addressing the target lesion.
* Target lesions in branch vessels that are in-stent restenosis.
* Other patients deemed unsuitable for inclusion by the investigator.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yuying Bi
• Email: ybi@ttmedicalinc.com
• Phone: +86 22215363

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• IVUS-Guided Left Main Stenting: IVUS-Guided vs Trained-Eye Approach

  This trial tests whether using IVUS to guide left main bifurcation stenting is as good as using an angiography-driven, experience-based approach by an IVUS-savvy operator.

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• Crossover vs Accurate Ostial Stenting for Left Main Bifurcation Lesions

  This observational study tests two stenting strategies for ostial lesions in the left main coronary artery to see which approach works better for patients with left main bifurcation disease.

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• Comparing two strategies for treating coronary bifurcation lesions

  This study is testing whether a new treatment using drug-eluting balloons is better than a two-stent approach for people with specific heart artery blockages to see which method helps them more and has fewer problems.

  Recruiting Cathreine BV · Eindhoven, North Brabant · NCT05731687

• Registry of stenting procedures for coronary bifurcation lesions

  This study is collecting information on how well stenting works for patients with specific heart artery blockages to see what happens to them over five years.

  Recruiting Meshalkin Research Institute of Pathology of Circulation · Novosibirsk, Novosibirsk Oblast · NCT03450577

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.