Sirolimus DEB in Coronary Bifurcation Lesions
Recruiting
N/A
Interventional Study
Coronary Bifurcation Lesions
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 280 (estimated)
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
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About This Trial
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…
Trial Locations
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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 mon…
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