REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Coronary Syndromes
- Sponsor
- Samsung Medical Center
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- cardiac death
- Last Updated
- 9 years ago
Overview
Brief Summary
Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients with coronary artery disease. However, a continued risk of clinical events even several years after the procedure is reported. Stent platform or polymer-associated inflammation may play a role.
Bioresorbable scaffold (BRS) is known to disappear 2 to 3 years after the implantation, which may result in the more favorable very long-term clinical outcomes compared with metallic stents. The initial clinical experiences of BRS in relatively simple lesion subsets were comparable to DESs.
BRS, however, is limited by the disadvantageous mechanical characteristics such as thick strut and the risk of fracture by overdilation. There is concern that BRS is less optimal for complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or diffuse long lesions. Real world registry is needed to test the feasibility and safety of BRS in these complex lesion subsets.
Investigators
Hyeon-Cheol Gwon
MD,PhD
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Subject must be between 19 and 70 years old.
- •Patients with a significant lesion in a de novo coronary artery: a percent diameter stenosis (DS) 50% with 1) a positive history of recurrent angina pectoris; (2) objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent); or (3) abnormal results of any invasive functional diagnostic test (eg, fractional flow reserve) or a percent DS ≥70% even in the absence of the above-mentioned ischemic signs or symptoms.
- •Patients are scheduled for coronary intervention
- •He/she or his/her legally authorized representative provides written informed consent
Exclusion Criteria
- •Experience of cardiopulmonary resuscitation
- •Cardiogenic shock
- •Expected survival less than 2 years
- •Pregnancy or breast feeding
- •Opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Outcomes
Primary Outcomes
cardiac death
Time Frame: 2 years
Target vessel failure (TVF) of cardiac death, myocardial infarction (MI) attributed to the target vessel, and target vessel revascularization (TVR)
Secondary Outcomes
- Device success(maximum of 7 days)
- Procedural success(maximum of 7 days)
- Target vessel failure (TVF)(1, 3, and 5 years)
- Each component of Target vessel failure (TVF)(1, 2, 3 and 5 years)
- Periprocedural enzyme elevation(1, 2, 3 and 5 years)
- Definite or probable stent thrombosis(1, 2, 3 and 5 years)
- Target lesion failure(1, 2, 3 and 5 years)