Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province

Yonsei University3 sites in 1 country5,000 target enrollmentJanuary 1, 2013

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Yonsei University
Enrollment: 5000
Locations: 3
Primary Endpoint: Device-oriented composite outcome
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 1, 2013

End Date

December 31, 2031

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Yonsei University

Responsible Party

Principal Investigator

Young Jin Youn, MD, PhD

Assistant Professor

Yonsei University

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Device-oriented composite outcome

Time Frame: 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