REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02601404|
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : March 3, 2017
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.
|Condition or disease||Intervention/treatment|
|Acute Coronary Syndromes||Device: Bioresorbable scaffold (BRS)|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Patients receiving percutaneous coronary intervention (PCI) for coronary artery disease using Absorb™(Abbott Vascular)
Device: Bioresorbable scaffold (BRS)
The implantation procedure of an Absorb™ is similar to a metallic stent.
Other Name: Absorb™ (Abbott Vascular)
- 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)
- Device success [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 1, 3, and 5 years ]cardiac death, target vessel MI, or TVR
- Each component of Target vessel failure (TVF) [ Time Frame: 1, 2, 3 and 5 years ]Cardiac death,Vascular death,Non-cardiovascular death,Myocardial Infarction (MI)
- Target lesion failure [ Time Frame: 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.
- Definite or probable stent thrombosis [ Time Frame: 1, 2, 3 and 5 years ]
- Periprocedural enzyme elevation [ Time Frame: 1, 2, 3 and 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601404
|Contact: HyeonCheol Gwon, MD,Ph.D.||2-3410-3418 ext email@example.com|
|Korea, Republic of|
|Cardiac and Vascular Center; Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Hyeon-Cheol Gwon, Professor 82234103419 firstname.lastname@example.org|