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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06075433
Other study ID # CR221008
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 5, 2021
Est. completion date December 31, 2025

Study information

Verified date October 2023
Source Genoss Co., Ltd.
Contact YoungJin Youn
Phone 033-741-0910
Email younyj@yonsei.ac.kr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In this prospective, multicenter observational study, The investigators evaluated the safety and effectiveness of DAPT over 1 year in all patients with coronary artery disease, including patients with complex high-risk coronary artery disease (CHIP), who underwent PCI using the Genoss DES stent, and performed subgroup analysis. Through this, the investigators aim to determine whether there are differences in safety and effectiveness depending on whether or not the patient is a subject with complex high-risk coronary artery disease.


Description:

This study is a sponsor-initiated clinical trial (SIT) that enrolls patients with coronary artery disease who underwent PCI using the GENOSS DES drug-eluting stent as research subjects, collects data on Honaza's clinical practice and procedures, and determines the occurrence of clinical events. The investigators will track this. This study is a prospective, multicenter study enrolling patients with coronary artery disease who underwent percutaneous coronary intervention with GENOSS DES. A total of eight institutions will recruit subjects. This study is a registered observation study and does not calculate a separate number of subjects, but plans to recruit a total of 1,000 subjects during the study registration period.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Adults aged 19 or older 2. Subjects treated for coronary artery disease using the Genoss DES™ stent 3. Subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and provide written consent in the research subject consent form. Exclusion Criteria: 1. Psychogenic shock at the time of hospitalization 2. Expecting to become pregnant, pregnant or lactating woman 3. In cases where the remaining survival period is expected to be less than 1 year due to a concomitant medical disease 4. Subjects participating in other medical device randomization studies 5. Subjects who received treatment using a different DES or BMS at the time of registration (however, due to failure of Genoss DES™ stent insertion, insertion of other stents is allowed)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Genoss DES stent
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 Wonju Severance Christian Hospital Wonju Gangwon State

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
Standardized bleeding criteria at 12 months (Bleeding Academic Research Consortium; see appendix) type 2 to 5 bleeding
12 months
Other Effectiveness evaluation All reperfusions at 12 months
Reperfusion of clinically appropriate target lesions at 12 months
12 months
Primary device-oriented composite end point cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, clinically indicated target-lesion revascularization 12 months
Secondary patient-oriented composite end point all-cause mortality, any myocardial infarction, any revascularization
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
All reperfusions at 12 months
Reperfusion of clinically appropriate target lesions at 12 months
Stent thrombosis by ARC definition at 12 months
Lesion success during the procedure: When the final remaining lesion stenosis is less than 30% using any surgical method.
Procedure success: When the final residual lesion stenosis is less than 30% using any surgical method, and there is no death, myocardial infarction, or reperfusion after the procedure during the hospitalization period.
12 months
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