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

Acute Coronary Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02601404
• Other study ID #: 2015-07-163
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2015
• Last updated: March 1, 2017
• Start date: November 2015
• Est. completion date: December 2022

Study information

• Verified date: March 2017
• Source: Samsung Medical Center
• Contact: HyeonCheol Gwon, MD,Ph.D.
• Phone: 2-3410-3418
• Email: hc.gwon[@]samsung.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes

Intervention

Device:
• Bioresorbable scaffold (BRS)
The implantation procedure of an Absorb™ is similar to a metallic stent.

Locations

Country	Name	City	State
Korea, Republic of	Cardiac and Vascular Center; Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac death	Target vessel failure (TVF) of cardiac death, myocardial infarction (MI) attributed to the target vessel, and target vessel revascularization (TVR)	2 years
Secondary	Device success	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).	maximum of 7 days
Secondary	Procedural success	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).	maximum of 7 days
Secondary	Target vessel failure (TVF)	cardiac death, target vessel MI, or TVR	1, 3, and 5 years
Secondary	Each component of Target vessel failure (TVF)	Cardiac death,Vascular death,Non-cardiovascular death,Myocardial Infarction (MI)	1, 2, 3 and 5 years
Secondary	Target lesion failure	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.	1, 2, 3 and 5 years
Secondary	Definite or probable stent thrombosis		1, 2, 3 and 5 years
Secondary	Periprocedural enzyme elevation		1, 2, 3 and 5 years