Gangwon PCI Prospective Registry

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT02038127
• Lead Sponsor: Yonsei University

Brief Summary

Comparison of

* Biolimus-eluting stent, Biomatrix, or Biomatrix Flex stent, Biosensors, Singapore

* Everolimus-eluting stent, Xience V, or Xience Prime, or Xience Xpedition stent, Abbott, USA

* Zotarolimus-eluting stent, Endeavor Resolute, or Endeavor Resolute Integrity stent Medtronic, USA in patients with coronary artery disease treated with percutaneous coronary intervention

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Primary Completion: 2030-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Age > 19 years
• Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the drug-eluting stent(s) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
• Subject must have significant stenosis (>50% by visual estimate) on a native or in-stent coronary artery
• Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, positive functional study or a reversible changes in the ECG consistent with ischemia). In subjects with coronary artery stenosis >75%, evidence of myocardial ischemia does not have to be documented

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Exclusion Criteria

• Subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, biolimus A9, everolimus, zotarolimus, stainless steel, cobalt chromium, contrast media (Patients with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.)
• Subject in use of systemic (intravenous) biolimus A9, everolimus or zotarolimus within 12 months.
• Female subject of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study
• Subject planned an elective surgical procedure that would necessitate interruption of antiplatelet during the first 12 months post enrollment
• Subject with non-cardiac co-morbid condition with life expectancy < 2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
• Subject with cardiogenic shock at presentation
• Subject who are actively participating in another drug or device investigational study, who have not completed the primary end point follow-up period

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device-oriented composite outcome	24 months	Device-oriented composite consisted of cardiac death, MI not clearly attributable to a nontarget vessel, and clinically indicated TLR at 24-month clinical follow-up

Secondary Outcome Measures

Name	Time	Method
ARC defined stent thrombosis	24 months
Target vessel revascularization	24 months
Patient-oriented composite outcome	24 months	Patient-oriented composite consisted of all-cause mortality, any MI, and any revascularization at 24-month clinical follow-up

Trial Locations

Locations (3)

Yonsei University Wonju Christian Hospital; 🇰🇷 Wonju, Gangwon, Korea, Republic of

Chuncheon Hallym University Hospital; 🇰🇷 Chuncheon, Gangwon, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of