Using Sirolimus-Coated Balloons for Treating Coronary Bifurcation Lesions
A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of the Sirolimus-coated Spiral Balloon Catheter for the Treatment of Coronary Bifurcation Lesions
This study is testing whether Sirolimus-coated balloons are safer and more effective than Paclitaxel-coated balloons for treating specific heart artery blockages in 280 patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Dongguan TT Medical Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06618248 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 to 85 with angiographically confirmed coronary bifurcation lesions and evidence of myocardial ischemia.
Not a fit: Patients with lesions requiring stenting on the branch or those with significant comorbidities that preclude participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with coronary bifurcation lesions, potentially improving their outcomes.
How similar studies have performed: Other studies have explored the use of drug-coated balloons in coronary interventions, indicating potential for success, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yuying Bi
- Email: ybi@ttmedicalinc.com
- Phone: +86 22215363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.