Gangwon PCI Registry

  • End date
    Dec 31, 2031
  • participants needed
  • sponsor
    Yonsei University
Updated on 5 August 2021
myocardial infarction
angina pectoris
unstable angina
percutaneous coronary intervention
coronary artery stenosis
arterial disease


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

Condition Cardiac Ischemia, Myocardial Ischemia, Coronary Artery Disease, Coronary heart disease
Clinical Study IdentifierNCT02038127
SponsorYonsei University
Last Modified on5 August 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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