Sirolimus DEB in Coronary Bifurcation Lesions
- Conditions
- Coronary Bifurcation Lesions
- Registration Number
- NCT04896177
- Lead Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 280
- Male or Female that ages 18-85 year old;
- Having evidence of myocardial ischemia;
- Voluntarily participates in this study and signs the informed consent form (ICF);
- 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;
- Angiography confirmed as de novo bifurcation lesion with side-branch stenosis (diameter) ≥70%;
- 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;
- Residual stenosis of the side-branch lesion ≦50% after pre-treatment, with a TIMI flow grade 3;
- The target vessel diameter was 2.0mm-4.0mm.
- Women who is pregnant or lactating, or having a fertility plan within 1 year or are unwilling to take effective contraceptive measures;
- Cardiogenic shock patients;
- 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;
- ST-segment elevation myocardial infarction (STEMI) occurred within one week before enrollment;
- With severe congestive heart failure or NYHA class Ⅳ heart failure;
- With severe valvuar heart disease;
- Heart transplant patients;
- With renal insufficiency (creatinine > 3.0mg/ dL or 265.2 umol /L) and/or advanced renal disease requiring dialysis;
- With a life expectancy less than 1 year;
- With contraindications who cannot take aspirin and/or clopidogrel and/or ticagrelor;
- With known allergies to paclitaxel, sirolimus, contrast agents, etc.;
- Participating in clinical trials of other drugs or devices and has not met the primary endpoint;
- Non-target lesions cannot be processed before the target lesions or non-target lesions treatment fails;
- Intra-stent restenosis;
- High-risk left main disease;
- Other patients considered by the investigator to be unsuitable for inclusion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Stenosis of lumen diameter of target lesion branch 9 months (±30 days) The degree of lumen diameter stenosis (%) =(1- the minimum lumen diameter of the vessel/the reference diameter of the target lesion vessel)×100%
- Secondary Outcome Measures
Name Time Method Success rate of interventional treatment Index Procedure Including device success, pathological success and clinical success
Target lesion failure rate (TLF) 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days) Including cardiac death, target vascular-associated myocardial infarction, and target lesion revascularization
Late lumen loss (LLL) 9 months (±30 days) Incidence of restenosis of target lesions 9 months (±30 days) Restenosis defined as angiographic stenosis ≥50%
Target vessel revascularization (TVR) 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days) Including PCI re-stenting, balloon dilation, plaque grinding or excision, coronary artery bypass grafting (CABG)
Target lesions revascularization (TLR) 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days) Including PCI re-stenting, balloon dilation, plaque grinding or excision, coronary artery bypass grafting (CABG)
Trial Locations
- Locations (1)
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital, Fudan University🇨🇳Shanghai, Shanghai, ChinaJiatian Cao, Dr.Contact+86 83867888amcjt@126.com