REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 3, 2017
March 1, 2017
7.1 years
November 5, 2015
March 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
Target lesion failure
1, 2, 3 and 5 years
- +2 more secondary outcomes
Study Arms (1)
Bioresorbable Scaffold
Patients receiving percutaneous coronary intervention (PCI) for coronary artery disease using Absorb™(Abbott Vascular)
Interventions
The implantation procedure of an Absorb™ is similar to a metallic stent.
Eligibility Criteria
A total of 1,000 patients derived from a population of Korean patients receiving PCI for coronary artery disease will be enrolled in the present registry. It is recommended that each enrolling investigator review the most recent instructions for use (IFU) of Absorb™ and assess the contraindications, warnings, and precaution sections for treating potential patients.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiac and Vascular Center; Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (1)
Lee JM, Joh HS, Choi KH, Hong D, Park TK, Yang JH, Song YB, Choi JH, Choi SH, Jeong JO, Lee JY, Choi YJ, Chae JK, Hur SH, Bae JW, Oh JH, Chun KJ, Kim HJ, Cho BR, Shin D, Lee SH, Hwang D, Lee HJ, Jang HJ, Kim HK, Ha SJ, Shin ES, Doh JH, Hahn JY, Gwon HC; SMART-REWARD Investigators. Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice. J Korean Med Sci. 2023 Feb 6;38(5):e34. doi: 10.3346/jkms.2023.38.e34.
PMID: 36747363DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 10, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
March 3, 2017
Record last verified: 2017-03