Genoss DES Prospective Multicenter Registry

Completed

• Conditions: Coronary Artery Disease; Myocardial Infarction; Myocardial Ischemia
• Interventions: Device: Genoss DES

• Registration Number: NCT03045913
• Lead Sponsor: Young Jin Youn, MD, PhD

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.

Study Timeline

• Study Start: 2016-11-18
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-02-03
• Study First Posted: 2017-02-08
• Primary Completion: 2021-11-29
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Genoss DES	Genoss DES	Subject implanted Genoss DES for coronary artery disease

Primary Outcome Measures

Name	Time	Method
Device-oriented composite end point (TLF)	12 months	Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Patient-oriented composite end point	12 months	Composite of any death, any myocardial infarction, and any revascularization
Clinically indicated target-lesion revascularization	12 months	Any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Any myocardial infarction	12 months	New symptom Symptoms suggestive of ischemia + increased cardiac enzyme (Troponin \>URL or CKMB \>URL) or New ST elevation or LBBB
Any myocardial infarction not clearly attributable to a nontarget vessel	12 months	Any myocardial infarction not clearly attributable to a nontarget vessel
ARC defined stent thrombosis	12 months	* Definite stent thrombosis; * Angiographic confirmation of stent thrombosis; * Pathological confirmation of stent thrombosis; * Probable stent thrombosis; - Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: * Possible stent thrombosis - Clinical definition of possible stent thrombosis is considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up.
Non-cardiac death	12 months	Any death not covered by the cardiac death
Any revascularization	12 months	Any repeat revascularization including all target and nontarget vessel
Clinically indicated target-vessel revascularization	12 months	any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
Cardiac death	12 months	Any death due to proximate cardiac cause, unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment

Trial Locations

Locations (17)

Chungbuk National University Hospital; 🇰🇷 Cheongju, Chungcheongbuk, Korea, Republic of

Dankook University Hospital; 🇰🇷 Cheonan, Chungcheongnam, Korea, Republic of

Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwon, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Chuncheon, Gangwon, Korea, Republic of

Gangneung Asan Hospital; 🇰🇷 Gangneung, Gangwon, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of

Myongji Hospital, Hanyang University College of Medicine; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of

National Health Insurance Service Ilsan Hospital; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of

CHA Bundang Medical Center; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of

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