Sirolimus DEB in Coronary Bifurcation Lesions
ConditionCoronary Bifurcation Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Sirolimus drug-eluting coronary balloon catheter
- Paclitaxel drug-eluting coronary balloon catheter
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov