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GWPCI: Gangwon PCI Registry

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02038127
Collaborator
Gangwon Cardiovascular Health Research Institute (Other)
5,000
Enrollment
3
Locations
227.9
Anticipated Duration (Months)
1666.7
Patients Per Site
7.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province
    Actual Study Start Date :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Dec 31, 2030
    Anticipated Study Completion Date :
    Dec 31, 2031

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Target vessel revascularization [12 months]

    3. Target vessel revascularization [24 months]

    4. ARC defined stent thrombosis [12 months]

    5. ARC defined stent thrombosis [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chuncheon Hallym University Hospital Chuncheon Gangwon Korea, Republic of
    2 Yonsei University Wonju Christian Hospital Wonju Gangwon Korea, Republic of 220768
    3 Korea University Guro Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University
    • Gangwon Cardiovascular Health Research Institute

    Investigators

    • Principal Investigator: Junghan Yoon, M.D., Ph.D., Yonsei University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Young Jin Youn, MD, PhD, Professor, Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02038127
    Other Study ID Numbers:
    • GangwonPCI
    First Posted:
    Jan 16, 2014
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Jul 27, 2021