Trials / Active Not Recruiting
Active Not RecruitingNCT06075368
Efficacy and Safety of GENOSS® SES in Patients With Acute Coronary Syndrome (GENOSS ACS)
A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS SES in Patients With Acute Coronary Syndrome
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 757 (actual)
- Sponsor
- Genoss Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-03-16
- Primary completion
- 2025-12-31
- Completion
- 2027-12-31
- First posted
- 2023-10-10
- Last updated
- 2026-02-11
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06075368. Inclusion in this directory is not an endorsement.