REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)

Samsung Medical Center

Status: Unknown

Conditions: Acute Coronary Syndromes

Treatments: Device: Bioresorbable scaffold (BRS)

Study type: Observational

Funder types: Other

Identifiers

NCT02601404

2015-07-163

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Bioresorbable Scaffold

Description:

Patients receiving percutaneous coronary intervention (PCI) for coronary artery disease using Absorb™(Abbott Vascular)

Treatment:

Device: Bioresorbable scaffold (BRS)