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

A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS SES in Patients With Acute Coronary Syndrome

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention
• Intervention / Treatment: Device: GENOSS Sirolimus Eluting Coronary Stent System

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 757

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute coronary syndrome treated with the GENOSS SES

Description

<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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]; Patients with acute coronary syndrome treated with the GENOSS SES	Device: GENOSS Sirolimus Eluting Coronary Stent System; The GENOSS SES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt chromium stent platform and thin strut.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-oriented composite endpoint	DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).	12 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion failure (TLF)	Target lesion failure (TLF) is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).	3 years after the procedure
Target vessel failure (TVF)	Target vessel failure (TVF) is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-vessel revascularization (TVR).	3 years after the procedure
All-cause death		3 years after the procedure
Cardiac death		3 years after the procedure
All-cause death and any myocardial infarction		3 years after the procedure
Cardiac death and target vessel-related myocardial infarction		3 years after the procedure
Target vessel revascularization (TVR)		3 years after the procedure
Target lesion revascularization (TLR)		3 years after the procedure
Stent thrombosis		3 years after the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation	Occurrence of stent-related events (cardiac death, myocardial infarction, stent thrombosis, bleeding, etc.) and any damage or complications that are believed to be related to the procedure.	1 month, 12 months, 2 years, 3 years after the procedure

Collaborators and Investigators

• Sponsor: Genoss Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2020
• Primary Completion (Actual): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: ACS
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Sirolimus
• Other Study ID Numbers: CIP-DS0501-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data set is available from the the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No