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

Coronary Artery Disease Clinical Trial

— GENOSSDES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06066476
• Other study ID #: CEP-DS0501
• Status: Recruiting
• Start date: February 28, 2018
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: Genoss Co., Ltd.
• Contact: InHo Chae
• Phone: 010-9700-1676
• Email: ihchae[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Genoss DES
The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Genoss Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Effectiveness evaluation	All reperfusions at 12 months; Reperfusion of clinically appropriate target lesions at 12 months	12 months
Primary	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	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