Genoss DES Prospective Multicenter Registry

Coronary Artery Disease Clinical Trial

Official title:

Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of GENOSS Sirolimus-eluting Stent in Patients With Coronary Artery Disease (GENOSS Registry)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045913
• Other study ID #: Yonsei University
• Status: Completed
• Start date: November 18, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: December 31, 2022
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• Genoss DES
The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Locations

Country	Name	City	State
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Dankook University Hospital	Cheonan	Chungcheongnam
Korea, Republic of	Chungbuk National University Hospital	Cheongju	Chungcheongbuk
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	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	Gachon University Gil Medical Center	Incheon
Korea, Republic of	CHA Bundang Medical Center	Seongnam	Gyeonggi
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Severance Cardiovascular Hospital	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon

Sponsors (2)

Lead Sponsor	Collaborator
Young Jin Youn, MD, PhD	Genoss Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device-oriented composite end point (TLF)	Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization	12 months
Secondary	Patient-oriented composite end point	Composite of any death, any myocardial infarction, and any revascularization	12 months
Secondary	Cardiac death	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	12 months
Secondary	Non-cardiac death	Any death not covered by the cardiac death	12 months
Secondary	Any myocardial infarction	New symptom Symptoms suggestive of ischemia + increased cardiac enzyme (Troponin >URL or CKMB >URL) or New ST elevation or LBBB	12 months
Secondary	Any myocardial infarction not clearly attributable to a nontarget vessel	Any myocardial infarction not clearly attributable to a nontarget vessel	12 months
Secondary	Any revascularization	Any repeat revascularization including all target and nontarget vessel	12 months
Secondary	Clinically indicated target-lesion revascularization	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.	12 months
Secondary	Clinically indicated target-vessel revascularization	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.	12 months
Secondary	ARC defined stent thrombosis	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.	12 months