Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2013-01-01
2031-12-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
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Gangwon Cardiovascular Health Research Institute
OTHER
Yonsei University
OTHER
Responsible Party
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Young Jin Youn, MD, PhD
Assistant Professor
Principal Investigators
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Junghan Yoon, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yonsei University
Locations
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Chuncheon Hallym University Hospital
Chuncheon, Gangwon-do, South Korea
Yonsei University Wonju Christian Hospital
Wŏnju, Gangwon-do, South Korea
Korea University Guro Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Jeon HS, Youn YJ, Lee JH, Park YJ, Son JW, Lee JW, Ahn MS, Ahn SG, Kim JY, Yoo BS, Yoon J. Safety and Efficacy of Two Ultrathin Biodegradable Polymer Sirolimus-Eluting Stents in Real-World Practice: Genoss DES Stents Versus Orsiro Stents From a Prospective Registry. Clin Cardiol. 2024 Dec;47(12):e70060. doi: 10.1002/clc.70060.
Jeon HS, Kim YI, Lee JH, Park YJ, Son JW, Lee JW, Youn YJ, Ahn MS, Kim JY, Yoo BS, Ko SM, Ahn SG. Failed Thrombus Aspiration and Reduced Myocardial Perfusion in Patients With STEMI and Large Thrombus Burden. JACC Cardiovasc Interv. 2024 Oct 14;17(19):2216-2225. doi: 10.1016/j.jcin.2024.07.016. Epub 2024 Sep 18.
Youn YJ, Jeon HS, Kim YI, Lee JH, Park YJ, Cho DH, Son JW, Lee JW, Ahn MS, Ahn SG, Kim JY, Yoo BS, Lee SH, Yoon J. Impact of the ultra-long 48 mm drug-eluting stent on procedural and clinical outcomes in patients with diffuse long coronary artery disease. Clin Cardiol. 2023 Apr;46(4):416-424. doi: 10.1002/clc.23997. Epub 2023 Feb 20.
Other Identifiers
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GangwonPCI
Identifier Type: -
Identifier Source: org_study_id
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