Status:
RECRUITING
Sirolimus DEB in Coronary Bifurcation Lesions
Lead Sponsor:
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Conditions:
Coronary Bifurcation Lesions
Eligibility:
All Genders
18-85 years
Phase:
NA
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, ...
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, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 18 2026
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04896177
Start Date
March 18 2021
End Date
September 18 2026
Last Update
May 21 2021
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000