Clinical trial NCT04896177: Sirolimus DEB in Coronary Bifurcation Lesions
Official title: A Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Trial to Evaluate the Efficacy and Safety of Sirolimus Drug-eluting Coronary Balloon Catheter in Treatment of Coronary Bifurcation Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Bifurcation Lesions
Keywords: drug-eluting balloon
coronary bifurcation lesions
coronary heart disease
sirolimus
Lead sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-21
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Stenosis of lumen diameter of target lesion branch
timeFrame: 9 months (±30 days)
Secondary outcomes:
measure: Success rate of interventional treatment
timeFrame: Index Procedure
measure: Incidence of restenosis of target lesions
timeFrame: 9 months (±30 days)
measure: Late lumen loss (LLL)
timeFrame: 9 months (±30 days)
measure: Target lesions revascularization (TLR)
timeFrame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
measure: Target vessel revascularization (TVR)
timeFrame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
measure: Target lesion failure rate (TLF)
timeFrame: 1 month (±7 days), 6 months (±14 days), 9 months (±30 days), 12 months (±30 days), 24 months (±30 days)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References: