Gangwon PCI Prospective Registry

Coronary Artery Disease Clinical Trial

— GWPCI  

Official title:

Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02038127
• Other study ID #: GangwonPCI
• Status: Recruiting
• Start date: January 1, 2013
• Est. completion date: December 31, 2031

Study information

• Verified date: January 2023
• Source: Yonsei University
• Contact: Junghan Yoon, M.D., Ph.D.
• Phone: +82-33-741-0906
• Email: jyoon[@]yonsei.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
Korea, Republic of	Chuncheon Hallym University Hospital	Chuncheon	Gangwon
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Yonsei University Wonju Christian Hospital	Wonju	Gangwon

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Gangwon Cardiovascular Health Research Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient-oriented composite outcome	Patient-oriented composite consisted of all-cause mortality, any MI, and any revascularization at 24-month clinical follow-up	24 months
Secondary	Target vessel revascularization		12 months
Secondary	Target vessel revascularization		24 months
Secondary	ARC defined stent thrombosis		12 months
Secondary	ARC defined stent thrombosis		24 months