Evaluating Efficacy and Safety of 1-year of DAPT After Genoss DES Sirolimus-eluting Stent Implantation in Patients

Coronary Artery Disease Clinical Trial

— DAPTLONG  

Official title:

Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of 1-year of Dual Antiplatelet Therapy After Genoss DES Sirolimus-eluting Stent Implantation in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075433
• Other study ID #: CR221008
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Dual Antiplatelet Therapy
• Myocardial Ischemia
• Percutaneous Coronary Intervention

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