Clinical trial NCT02038127: Gangwon PCI Prospective Registry
Official title: Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Gangwon Cardiovascular Health Research Institute
First posted: 2014-01-16
Enrollment: 5000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were at least 18 years of age, who have stable coronary artery disease (CAD) or acute coronary syndrome (ACS), including myocardial infarction (MI) with or without ST-segment elevation will be included in the study.

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


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

Primary outcomes:
measure: Device-oriented composite outcome
timeFrame: 24 months
Secondary outcomes:
measure: Patient-oriented composite outcome
timeFrame: 24 months
measure: Target vessel revascularization
timeFrame: 12 months
measure: Target vessel revascularization
timeFrame: 24 months
measure: ARC defined stent thrombosis
timeFrame: 12 months
measure: ARC defined stent thrombosis
timeFrame: 24 months
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Hallym University Hospital
state: Gangwon
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Christian Hospital
state: Gangwon
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Yonsei University
name: Junghan Yoon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: