Recruiting NCT02038127
Gangwon PCI Prospective Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province
Overview
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
Primary outcome measures
- Device-oriented composite outcome [Time frame: 24 months]
Secondary outcome measures (5)
- Patient-oriented composite outcome [Time frame: 24 months]
- Target vessel revascularization [Time frame: 12 months]
- Target vessel revascularization [Time frame: 24 months]
- ARC defined stent thrombosis [Time frame: 12 months]
- ARC defined stent thrombosis [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 3 centers
- Chuncheon Hallym University Hospital — Chuncheon
- Yonsei University Wonju Christian Hospital — Wŏnju
- Korea University Guro Hospital — Seoul
Publications
- 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 39691038
- 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. PMID 39297854
- 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. PMID 36807273
Identifiers
NCT: NCT02038127 · GangwonPCI