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Clinical Trials in China / NCT04896177
Recruiting Not applicable

Sirolimus DEB in Coronary Bifurcation Lesions

NCT04896177 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Phase
Not applicable
Started
2021-03-18
Last updated
2021-05-21

Condition(s) studied

Coronary Bifurcation Lesions

Investigational drug(s) / intervention(s)

Sirolimus drug-eluting coronary balloon catheterPaclitaxel drug-eluting coronary balloon catheter

Sirolimus drug-eluting coronary balloon catheter: Patients in experimental group will undergo PCI, using sirolimus drug-eluting coronary balloon catheter.Subjects without stent implantation were regularly treated with dual antiplatelet for 9 months after surgery. Subjects with stents were regularly treated with dual antiplatelet for 12 months after the surgery, in accordance with the applicable guidelines for percutaneous coronary intervention.

Paclitaxel drug-eluting coronary balloon catheter: Patients in control group will undergo PCI, using paclitaxel drug-eluting coronary balloon catheter.Subjects without stent implantation were regularly treated with dual antiplatelet for 9 months after surgery. Subjects with stents were regularly treated with dual antiplatelet for 12 months after the surgery, in accordance with the applicable guidelines for percutaneous coronary intervention.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting

More Shenzhen Salubris Pharmaceuticals Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04896177 on ClinicalTrials.gov ↗ ← All trials in China