Efficacy and Safety of GENOSS® DES in Patients with Coronary Artery Disease

NCT ID: NCT06066476

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1022 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-24
• Study Completion Date: 2024-10-31

Brief Summary

The objective of this study is to evaluate the efficacy and safety of the GENOSS DES in patients with coronary artery disease in real-world pratice.

Detailed Description

The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of the Genoss DES in all-comer patients undergoing percutaneous coronary intervention.

The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss DES implantation in all-comer patients undergoing percutaneous coronary intervention from 12 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

GENOSS Sirolimus Eluting Coronary Stent System

Patients with coronary artery disease treated with the GENOSS DES

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patients of 19 and over

2. Patients eligible for treatment of coronary artery disease using GENOSSTM DES

3. Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as research participants.

Exclusion Criteria

1. Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents (However, patients with hypersensitivity to contrast agents may be eligible if it can be controlled by steroids and pheniramine. Patients with known anaphylaxis are excluded)

2. Patients who are pregnant or planning to become pregnant

3. Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration

4. Patients with a life expectancy of less than 1 year

5. Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment

6. Patients who have already received treatment with another DES (Drug Eluting Stent), BVS (Bioresorbable Vascular Scaffolds), or BMS (Bare Metal Stent) at the time of registration

7. Patients currently participating in a randomized controlled trial involving medical devices

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genoss Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CIP-DS0501-08

Identifier Type: -

Identifier Source: org_study_id