Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of GENOSS Sirolimus-eluting Stent in Patients With Coronary Artery Disease (GENOSS Registry)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Young Jin Youn, MD, PhD
- Enrollment
- 2000
- Locations
- 17
- Primary Endpoint
- Device-oriented composite end point (TLF)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
Detailed Description
Percutaneous coronary intervention (PCI) is the main stream of treatment of coronary artery disease. Drug-eluting stents (DES) have dramatically reduced the rates of restenosis and target lesion revascularization (TLR) compared with bare-metal stents (BMS). Newer-generation DES with a durable polymer such as Xience (Abbott, US) and Resolute (Medtronic, US) were widely used. However, the concern about late stent thrombosis due to hypersensitivity reaction from the polymer is still existed. Recently, DES with a biodegradable polymer such as Biomatrix (Biosensors, Switzerland), Nobori (Terumo, Japan), Orsiro (Biotronik, Switzerland), and Synergy (Boston Scientific, US) was rapidly adopted and it is expected to reduce the late stent thrombosis. Recently, new biodegradable DES with thin struts was developed in South Korea. The Genoss DES (Genoss, Korea) has an L-605 cobalt chromium (CoCr) platform with a strut thickness of about 70 µm and the stent is coated a combination of Sirolimus drug with concentration of 1.15µg/mm2 and an abluminal biodegradable PLA and PLGA polymers. This study is conducted to evaluate efficacy and safety of Genoss DES in the treatment of patients with coronary artery disease.
Investigators
Young Jin Youn, MD, PhD
Professor
Yonsei University
Eligibility Criteria
Inclusion Criteria
- •Subject is ≥ 19 years
- •Subject implanted Genoss DES within 1 month
- •Subject has signed informed consent for data release
- •Subject is geographically stable and willing to participate at all follow-up assessments
Exclusion Criteria
- •Subject did not sign informed consent for data release
- •Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media
- •Pregnancy
- •Subject with life expectancy less than 12 months
- •Subject with cardiogenic shock
- •Planned surgery within 12 months of PCI unless dual antiplatelet therapy will be maintained
- •Currently participating in another study and primary endpoint is not reached yet.
Outcomes
Primary Outcomes
Device-oriented composite end point (TLF)
Time Frame: 12 months
Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization
Secondary Outcomes
- Patient-oriented composite end point(12 months)
- Clinically indicated target-lesion revascularization(12 months)
- Any myocardial infarction(12 months)
- Any myocardial infarction not clearly attributable to a nontarget vessel(12 months)
- ARC defined stent thrombosis(12 months)
- Non-cardiac death(12 months)
- Any revascularization(12 months)
- Clinically indicated target-vessel revascularization(12 months)
- Cardiac death(12 months)