Evaluating Efficacy and Safety of GENOSS Stent in Patients With Coronary Artery Disease (GENOSSDES)

Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of GENOSS Sirolimus-eluting Stent in Patients With Coronary Artery Disease

The purpose of this study is to evaluate the safety and effectiveness of the GENOSS stent in patients with coronary artery disease who underwent treatment using the GENOSS stent manufactured with domestic technology.

Study Overview

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

Detailed Description

This study is a prospective, registered observational study that is recruiting patients with coronary artery disease who underwent treatment using the GENOSS stent at a total of 6 institutions.

This study is a registered observation study and does not calculate a separate number of subjects. A total of 1,200 subjects are scheduled to be registered during the study subject registration period.

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Inho Chae; Phone Number: 010-9700-1676; Email: ihchae@snu.ac.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Inho Chae; Phone Number: 010-9700-1676; Email: ihchae@snu.ac.kr

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving coronary artery disease treatment using Genoss stent

Description

Inclusion Criteria:

1. Research subjects aged 19 years or older
2. Those eligible for coronary artery disease treatment
3. Research subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and give written consent in the research subject consent form.

Exclusion Criteria:

1. Research subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, cobalt chromium, contrast medium (however, even research subjects with hypersensitivity to contrast medium can be controlled with steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded)
2. Subjects who are women of childbearing age and planning to become pregnant during this study period
3. Subjects scheduled for surgery that requires discontinuation of antiplatelet medication within 12 months from registration
4. Those whose remaining life expectancy is less than 1 year
5. Patients who visited the hospital due to psychogenic shock and whose chances of survival are predicted to be low based on medical judgment
6. Subjects who received treatment using a different DES (Drug Eluting Stent), BVS (Bioresorbable vascular scaffolds), or BMS (Bare metal stent) on the same vascular adjacent lesion at the time of registration
7. Subjects participating in medical device randomization research

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with device-oriented compopsite endpoint (TLF)	A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with patient-oriented composite endpoint	A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR); All death; Psychogenic death; Non-cardiac death; All myocardial infarctions; All myocardial infarctions that are not clearly related to non-target vessels; All reperfusions; Reperfusion of clinically appropriate target lesions; Lesion success during the procedure: When the final remaining lesion stenosis is less than 50% using any surgical method.; Procedure success: When the final residual lesion stenosis is less than 50% using any surgical method, and there is no death, myocardial infarction, or reperfusion after the procedure during the hospitalization period.	12 months

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): February 28, 2018
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 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): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

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

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