Prospective Registry of Patients With Acute Coronary Syndrome Treated With GENOSS Stent

Acute Coronary Syndrome Clinical Trial

— GENOSSACS  

Official title:

A Multi-center Prospective Registry of Patients With Acute Coronary Syndrome (ACS) Treated With GENOSSTM Sirolimus-eluting Stent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075368
• Other study ID #: B-1909-564-302
• Status: Recruiting
• Start date: February 17, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Genoss Co., Ltd.
• Contact: InHo Chae
• Phone: 010-9700-1676
• Email: ihchae[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The investigators intend to establish a multi-center prospective observational study to evaluate the effectiveness and safety of Genoss DES by registering and tracking patients treated for acute coronary syndrome (ACS) as research subjects using Genoss DES, which was manufactured purely with domestic technology.

Description:

This study is a sponsor-initiated clinical trial (SIT) that will enroll patients treated for acute coronary syndrome using the GENOSS stent as research subjects, collect data on the patients' clinical and surgical procedures, and track the occurrence of clinical events. .

This study is a prospective, multicenter registration observational study enrolling patients with acute coronary artery disease treated using the GENOSS stent at a total of 10 institutions.

Since this study is a registered observation study, the number of subjects is not calculated separately, but a total of 1,000 subjects are scheduled to be recruited 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 over 19 years of age

2. Patients who underwent Genoss DES for acute coronary syndrome (ACS)

3. Patients who agreed in writing to participate in this registry study

Exclusion Criteria:

1. Patients for whom the subject or the subject's representative did not consent to participation in the study

2. Patients who received a stent other than Genoss DES inserted into a lesion adjacent to the same blood vessel during the PCI procedure on the relevant procedure day.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Percutaneous Coronary Intervention
• Syndrome

Intervention

Device:
• Genoss DES
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	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

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
Primary	device-oriented composite end point	A composite index of cardiac death, any myocardial infarction not clearly attributable to a non-target vessel, and target-lesion revascularization.	12 months
Secondary	Number of participants with patient-oriented composite endpoint	Target lesion treatment failure up to 3 years after stent insertion; Failure of target vessel treatment up to 3 years after stent insertion (cardiogenic death, myocardial infarction, target vessel revascularization (TVR)); All cause death up to 3 years after stent insertion; Cardiac death up to 3 years after stent insertion; All-cause mortality and myocardial infarction up to 3 years after stent insertion; Cardiogenic death and myocardial infarction up to 3 years after stent insertion; Target vessel revascularization up to 3 years after stent insertion; Target lesion revascularization up to 3 years after stent insertion; Occurrence of stent thrombosis up to 3 years after stent insertion	3 years