A Randomized Controlled Trial of the Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in Patients With Coronary Artery Disease: BIOHEART-II
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Shanghai Bio-heart Biological Technology Co., Ltd.
- Enrollment
- 431
- Locations
- 25
- Primary Endpoint
- in segment late luminal loss
- Last Updated
- 6 years ago
Overview
Brief Summary
The Bioheart Randomized Controlled Trial is a prospective multicentred paralleled study, which will enroll 430 patients and randomized 1:1 to study group and control group. Aim to assess the efficacy and safety of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System compare with XIENCE stent in the treatment of patients with up to two coronary lesions.
Detailed Description
This study is a prospective, multicentred randomized controlled trial, planning to enroll 430 subjects and randomize 1:1 to study group and control group. All subjects will accept clinical evaluation at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5 year post procedure. All subjects will accept angiographic evaluation at 1 year post procedure, and simutaneously 80 subjects (40 in study group and 40 in control group) will accepted OCT evaluation. To assess the efficacy and safety, the primary endpoint will be in segment late luminal loss at 1 year post procedure, the secondary endpoint is neointima coverage percentage of stent strut (%) at 1 year post procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •subjects that participate in this study must fulfill all the following criteria:
- •general inclusion criteria:
- •Age from 18 to 75 years old, man or non-pregnant woman;
- •Subjects with asymptomatic ischemic evidence, stable or unstable angina, or old myocardial infarction, suitable for selective PCI;
- •Subjects without contraindications of coronary artery bypass grafting (CABG);
- •Subjects are able to understand the purpose of this study, volunteer to participate and sign informed consent, willing to accept invasive imaging follow-up.
- •Angiographic inclusion criteria:
- •One or two de novo target lesions
- •If subject has only one target lesion, the second non-target lesion can be treated but this non-target lesion must locate in a different epicardial vessel, and must be treated first and be treated successfully prior to the subjects' randomization.
- •If there are two target lesions, they must locate in different epicardial vessels and both satisfy the angiographic eligibility criteria.
Exclusion Criteria
- •If subjects fulfill any of below criterias, this subject shall be exclude from this study.
- •general exclusion criteria:
- •Any newly onset acute myocardial infarction within 1 week or, myocardial enzymes does not return to normal level after myocardial infarction;
- •Target lesion has any stents implant history within 1 year or subjects planning to receive percutaneous artery intervention within half one year;
- •Subjects with severe heart failure (≥ grade III NYHA) or left ventricular ejection fraction \<35% (accessed by ultrasound or left ventricular angiography)
- •Preprocedure severe kidney functional damaged: serum creatinine\> 2.0mg /dl (176.8μmol / L) or subject is receiving hemodialysis;
- •Subjects with bleeding tendency, active gastrointestinal ulcers, history of cerebral hemorrhage or history of subarachnoid hemorrhage, history within six months of ischemic stroke, contraindications of anti-platelet agents and anticoagulants treatment, and subjects cannot receive anti-thrombolytic therapy;
- •Hypersensitive or allergic to aspirin, clopidogrel, heparin, contrast agent, polylactic acid polymer， rapamycin;
- •The subject's life expectancy is less than 24 months;
- •Subjects participated in other drug or medical device clinical trial and have not reach the primary endpoint;
Outcomes
Primary Outcomes
in segment late luminal loss
Time Frame: 1 year post procedure
In-segment late loss is defined as the change in minimal lumen diameter (MLD) from post-procedure to 1 year by angiography，in segment is defined within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.
neointima coverage percentage of stent strut (%)
Time Frame: 1 year post procedure
only in OCT subgroup
Secondary Outcomes
- target lesion revascularization(at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure)
- device success(immediately post procedure)
- clinical success(at 1 month post procedure)
- Patient oriented composite endpoint (PoCE)(at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure)
- any coronary revascularization(at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure)
- ARC--defined stent thrombosis(at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure)
- myocardial infarction (MI)(at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure)
- target vessel revascularization(at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure)
- lesion success(immediately post procedure)
- Device oriented composite endpoint (DoCE)/target lesion failure (TLF)(at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure)
- death(at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure)