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

NCT06841510 | Active Not Recruiting

• 1 other identifier: CIP-DS0501-09
• Study Type: observational
• Target: 1,118
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Arterial Disease (CAD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Patient-oriented composite endpoint

  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

Study Arms (1)

GENOSS Sirolimus Eluting Coronary Stent System

patients with coronary artery disease treated with GENOSS SES

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery disease treated with GENOSS SES

You may qualify if:

• Patients of 19 and over
• Patients with coronary artery disease treated with GENOSS SES
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Genoss Co., Ltd.: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 24, 2025
• Study Start: April 19, 2018
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)