Gangwon PCI Prospective Registry

NCT ID: NCT02038127

Last Updated: 2024-07-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2031-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangwon Cardiovascular Health Research Institute

OTHER

Sponsor Role collaborator

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Young Jin Youn, MD, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status NOT_YET_RECRUITING

Yonsei University Wonju Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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

Role: CONTACT

+82-33-741-0906

Young Jin Youn, M.D.

Role: CONTACT

+82-33-741-0917

Facility Contacts

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Hyun Hee Choi, M.D.

Role: primary

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

Role: primary

+82-33-741-0906

Cheol Ung Choi, M.D., Ph.D.

Role: primary

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.

Reference Type DERIVED
PMID: 39691038 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39297854 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36807273 (View on PubMed)

Other Identifiers

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GangwonPCI

Identifier Type: -

Identifier Source: org_study_id

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