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

NCT06086496 | Enrolling By Invitation

• 1 other identifier: 2022AN0320
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF)

  The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)

  at 12 months after the procedure

Secondary Outcomes (8)

• All deaths

  at 12 months after the procedure

• Cardiac death

  at 12 months after the procedure

• TV-MI (target vessel-myocardial infarction)

  at 12 months after the procedure

• any MI (myocardial infarction)

  at 12 months after the procedure

• ID-TVR (ischemia-driven target vessel revascularization)

  at 12 months after the procedure

Study Arms (1)

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)

Device: GENOSS® DES Sirolimus Eluting Coronary Stent System

Interventions

GENOSS® DES Sirolimus Eluting Coronary Stent System 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.

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Coronary artery disease patients who underwent coronary intervention using the GENOSS® DES

You may qualify if:

• Adults over 19 years of age
• Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
• Severe coronary artery stenosis suitable for GENOSS® DES insertion
• 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.

You may not qualify if:

• 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)
• Patients who also received other drug-eluting stents
• If you have a disease with a remaining life expectancy of less than 1 year
• Pregnant or lactating women or women who may be pregnant
• 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.
• Patients judged by researchers to be unsuitable for research

Sponsors & Collaborators

• Genoss Co., Ltd.: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 17, 2023
• Study Start: July 15, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)