GENOSSDES: Evaluating Efficacy and Safety of GENOSS Stent in Patients With CAD
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Outcome Measures
Primary Outcome Measures
- Number of participants with device-oriented compopsite endpoint (TLF) [12 months]
A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR)
Secondary Outcome Measures
- Number of participants with patient-oriented composite endpoint [12 months]
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.
Other Outcome Measures
- Safety evaluation [12 months]
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
- Effectiveness evaluation [12 months]
All reperfusions at 12 months Reperfusion of clinically appropriate target lesions at 12 months
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Research subjects aged 19 years or older
-
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:
-
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)
-
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
-
Those whose remaining life expectancy is less than 1 year
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Bundang Hospital | Seongnam | Gyeonggi-do | Korea, Republic of | 13620 |
Sponsors and Collaborators
- Genoss Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CEP-DS0501