Gangwon PCI Prospective Registry
GWPCI
Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province
1 other identifier
observational
5,000
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 14, 2014
CompletedFirst Posted
Study publicly available on registry
January 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
July 24, 2024
July 1, 2024
18 years
January 14, 2014
July 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Device-oriented composite outcome
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
24 months
Secondary Outcomes (5)
Patient-oriented composite outcome
24 months
Target vessel revascularization
12 months
Target vessel revascularization
24 months
ARC defined stent thrombosis
12 months
ARC defined stent thrombosis
24 months
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Chuncheon Hallym University Hospital
Chuncheon, Gangwon-do, South Korea
Yonsei University Wonju Christian Hospital
Wŏnju, Gangwon-do, 220768, South Korea
Korea University Guro Hospital
Seoul, South Korea
Related Publications (3)
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.
PMID: 39691038DERIVEDJeon 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.
PMID: 39297854DERIVEDYoun 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.
PMID: 36807273DERIVED
Biospecimen
CBC, Electrolyte, Chemistry, Cardiac biomarker, Platelet function test
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Junghan Yoon, M.D., Ph.D.
Yonsei University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 14, 2014
First Posted
January 16, 2014
Study Start
January 1, 2013
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2031
Last Updated
July 24, 2024
Record last verified: 2024-07