Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent (GENOSS® DES)

NCT ID: NCT06086496

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2027-12-31

Brief Summary

In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.

Detailed Description

This study is a sponsor-initiated clinical trial (SIT) that enrolls patients who underwent percutaneous coronary intervention using the GENOSS® DES drug-eluting stent.

As it is a prospective, multicenter, observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants at 7 institutions during the study registration period.

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]

Patients with coronary artery disease who require interventional treatment through stent insertion in real-world practice (all-comer)

GENOSS® DES Sirolimus Eluting Coronary Stent System

Intervention Type: DEVICE

The GENOSS® DES is L-605 cobalt chromium (CoCr) platform with a strut thickness of 70µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Interventions

GENOSS® DES Sirolimus Eluting Coronary Stent System

The GENOSS® DES is L-605 cobalt chromium (CoCr) platform with a strut thickness of 70µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adults over 19 years of age

2. Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.

3. Severe coronary artery stenosis suitable for GENOSS® DES insertion

4. Patients who agree to the research protocol and clinical follow-up plan and give written informed consent in the consent form approved by the Institutional Review Board/Ethics Committee of each research institution.

Exclusion Criteria

1. Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded)

2. Patients who also received other drug-eluting stents

3. If you have a disease with a remaining life expectancy of less than 1 year

4. Pregnant or lactating women or women who may be pregnant

5. Cases in which the patient was admitted to the hospital due to psychogenic shock and the likelihood of survival is medically expected to be low.

6. Patients judged by researchers to be unsuitable for research

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genoss Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Korea University Anam Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

2022AN0320

Identifier Type: -

Identifier Source: org_study_id