sirolimus deb in coronary bifurcation lesions

Conditions: Coronary Bifurcation Lesions

Summary: the purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions. this is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. paticipants would undergoing pci with sirolimus deb or paclitaxel deb, and be followed-up to 24 months.

the purpose of this study is to evaluate the efficacy and safety of sirolimus drug-eluting coronary balloon catheter in treatment of coronary bifurcation lesions. this is a prospective, multicenter, randomized controlled, non-inferior clinical trial, which would enroll 280 participants in total. paticipants with would undergoing pci with sirolimus deb or paclitaxel deb, and be followed-up to 24 months.

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.

Keywords: drug-eluting balloon coronary bifurcation lesions coronary heart disease sirolimus