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

NCT06066476 | Completed

• 1 other identifier: CIP-DS0501-08
• Study Type: observational
• Target: 1,022
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

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 the GENOSS DES

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 DES

You may qualify if:

• Patients of 19 and over
• Patients eligible for treatment of coronary artery disease using GENOSSTM DES
• 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.

You may not qualify if:

• 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)
• Patients who are pregnant or planning to become pregnant
• Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration
• Patients with a life expectancy of less than 1 year
• Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment
• 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
• Patients currently participating in a randomized controlled trial involving medical devices

Sponsors & Collaborators

• Genoss Co., Ltd.: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

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: September 27, 2023
• First Posted: October 4, 2023
• Study Start: June 24, 2017
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)