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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02601404
Other study ID # 2015-07-163
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Bioresorbable scaffold (BRS)
The implantation procedure of an Absorbâ„¢ 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
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