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

• Conditions: Acute Coronary Syndromes
• Interventions: Device: Bioresorbable scaffold (BRS)

• Registration Number: NCT02601404
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-08
• Study First Posted: 2015-11-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bioresorbable Scaffold	Bioresorbable scaffold (BRS)	Patients receiving percutaneous coronary intervention (PCI) for coronary artery disease using Absorb™(Abbott Vascular)

Primary Outcome Measures

Name	Time	Method
cardiac death	2 years	Target vessel failure (TVF) of cardiac death, myocardial infarction (MI) attributed to the target vessel, and target vessel revascularization (TVR)

Secondary Outcome Measures

Name	Time	Method
Device success	maximum of 7 days	Successful delivery and deployment of the study scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable).
Procedural success	maximum of 7 days	Achievement of final in-scaffold residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat target lesion revascularization (TLR) during the hospital stay (maximum of 7 days).
Target vessel failure (TVF)	1, 3, and 5 years	cardiac death, target vessel MI, or TVR
Each component of Target vessel failure (TVF)	1, 2, 3 and 5 years	Cardiac death,Vascular death,Non-cardiovascular death,Myocardial Infarction (MI)
Definite or probable stent thrombosis	1, 2, 3 and 5 years
Periprocedural enzyme elevation	1, 2, 3 and 5 years
Target lesion failure	1, 2, 3 and 5 years	Target lesion failure of cardiac death, MI attributed to the target vessel, and Target Lesion Revascularization(TLR). TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.

Trial Locations

Locations (1)

Cardiac and Vascular Center; Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of