Gangwon PCI Registry

STATUS

Recruiting
End date

Dec 31, 2031
participants needed

5000
sponsor

Yonsei University

Send

Updated on 5 August 2021

See if I qualify

stenosis

everolimus

myocardial infarction

angina pectoris

unstable angina

infarct

percutaneous coronary intervention

ischemia

coronary artery stenosis

zotarolimus

arterial disease

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

Details

Condition	Cardiac Ischemia, Myocardial Ischemia, Coronary Artery Disease, Coronary heart disease
Clinical Study Identifier	NCT02038127
Sponsor	Yonsei University
Last Modified on	5 August 2021

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Eligibility		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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Step 2 Get screened

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Step 3 Enroll in the clinical study

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Step 4 Get your study results

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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Similar trials to consider

Browse trials for

stenosis

everolimus

myocardial infarction

angina pectoris

unstable angina

infarct

percutaneous coronary intervention

ischemia

coronary artery stenosis

zotarolimus

arterial disease

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Gangwon PCI Registry