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

A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS DES in Patients with Coronary Artery Disease

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Genoss DES

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.

• Study Type: Observational
• Enrollment (Actual): 1022

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery disease treated with GENOSS DES

Description

<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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
GENOSS Sirolimus Eluting Coronary Stent System; Patients with coronary artery disease treated with the GENOSS DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-oriented composite endpoint	DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).	at 12 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-oriented composite endpoint	POCE is defined as a composite of all-cause death, any myocardial infarction, and any revascularization.	at 12 months after the procedure
All-cause deaths		at 12 months after the procedure
Cardiac death		at 12 months after the procedure
Non-cardiac death		at 12 months after the procedure
Any myocardial infarction		at 12 months after the procedure
target vessel-related myocardial infarction (TV-MI)		at 12 months after the procedure
Any revascularization		at 12 months after the procedure
Clinically indicated target lesion revascularization (TLR)		at 12 months after the procedure
Stent thrombosis		at 12 months after the procedure
Lesion success	When the final residual lesion stenosis is less than 50% using any surgical method.	during the procedure
Procedure success	When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedure death, myocardial infarction, or revascularization during the hospitalization period.	immediately after the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation	All deaths at 12 months; Psychogenic death at 12 months; Non-cardiac death at 12 months; All myocardial infarctions at 12 months; All myocardial infarctions that are not clearly related to non-target vessels at 12 months	12 months
Effectiveness evaluation	All reperfusions at 12 months; Reperfusion of clinically appropriate target lesions at 12 months	12 months

Collaborators and Investigators

• Sponsor: Genoss Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2017
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CIP-DS0501-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data set is available from the the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No