Efficacy and Safety of GENOSS SES in Patients With Coronary Artery Disease (GENOSS SES)

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

Efficacy and Safety of GENOSS SES in patients with coronary artery disease

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Arterial Disease (CAD)

Detailed Description

GENOSS SES

• Study Type: Observational
• Enrollment (Actual): 1118

Contacts and Locations

Study Locations

• South Korea
  • Seongnam, South Korea, 13620
    • Seoul National University Bundang 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 SES

Description

Inclusion Criteria:

1. Patients of 19 and over
2. Patients with coronary artery disease treated with GENOSS SES
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 study participants

Exclusion Criteria:

1. Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents
2. Patients who are pregnant or planning to become pregnant
3. Patients with a planned surgery to discontinue antiplatelet agents within 12 months
4. Patients with a life expectancy of less than 1 year
5. Patient with cardiogenic shock at the time of hospitalization and had a low chance of survival based on medical judgment.
6. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration
7. Patients participating in randomized controlled trials using other 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 GENOSS SES

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
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
Target vessel-related myocardial infarction (TV-MI)		at 12 months after the procedure

Collaborators and Investigators

• Sponsor: Genoss Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 15, 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-DS0501-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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