Acute Coronary Syndromes
Conditions
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.
Interventions
DEVICEBioresorbable scaffold (BRS)
The implantation procedure of an Absorb™ is similar to a metallic stent.
Sponsors
Samsung Medical Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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). |
| 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. |
Countries
South Korea
Contacts
Primary ContactHyeonCheol Gwon, MD,Ph.D.
Outcome results
None listed