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Recruiting

NCT Number: NCT02038127

Gangwon PCI Prospective Registry

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

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chuncheon Hallym University Hospital, Chuncheon, Gangwon-do, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Patient-oriented composite outcome

    Time frame: 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

    Time frame: 12 months

  3. Target vessel revascularization

    Time frame: 24 months

  4. ARC defined stent thrombosis

    Time frame: 12 months

  5. ARC defined stent thrombosis

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Junghan Yoon, M.D., Ph.D.

CONTACT

[email protected]

+82-33-741-0906

Young Jin Youn, M.D.

CONTACT

[email protected]

+82-33-741-0917

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Gangwon Cardiovascular Health Research Institute

Registry information

Official study title

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

Acronym: GWPCI

Important dates

Study start
2013
Primary completion
2030
Study completion
2031
First posted
Jan 16, 2014
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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