Efficacy and Safety of GENOSS® SES in Patients with Acute Coronary Syndrome (GENOSS ACS)

Genoss

Status: Active, not recruiting

Conditions: Percutaneous Coronary Intervention; Acute Coronary Syndrome

Treatments: Device: GENOSS Sirolimus Eluting Coronary Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT06075368

CIP-DS0501-10

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy and safety of the GENOSS SES in patients with acute coronary syndrome (ACS) in real-world pratice.

Full description

The Genoss SES is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of the Genoss SES in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention.

The Genoss SES study is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss SES implantation in ACS patients undergoing percutaneous coronary intervention from 10 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 10 months.

Enrollment: 757 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

<Inclusion Criteria>

1. Patients of 19 and over
2. Patients with acute coronary syndrome treated with GENOSS SES
3. Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants.

<Exclusion Criteria>

1. Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents

   • However, patients with hypersensitivity to contrast agents may be eligible if it can be controlled by steroids and pheniramine. Patients with known anaphylaxis are excluded

2. Patients who are pregnant or planning to become pregnant

3. Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration.

4. Patients with a life expectancy of less than 1 year

5. Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment.

6. Patients who have already received treatment with another DES (Drug Eluting Stent), BVS (Bioresorbable Vascular Scaffolds), or BMS (Bare Metal Stent) at the time of registration.

7. Patients currently participating in a randomized controlled trial involving medical devices.

Trial design

757 participants in 1 patient group

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

Description:

Patients with acute coronary syndrome treated with the GENOSS SES

Treatment:

Device: GENOSS Sirolimus Eluting Coronary Stent System