Trials / Enrolling By Invitation
Enrolling By InvitationNCT06168305
Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease
Safety and Effectiveness of GENOSS® DES (Sirolimus-eluting Coronary Stent System) in Patients With Multivessel Coronary Artery Disease (MVCAD): A Multicenter, Prospective, Observational Study
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Genoss Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- —
Summary
The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease (MVCAD) using Genoss DES, a device manufactured with pure domestic technology. The study aims to evaluate the efficacy and safety of Genoss DES in MVCAD patients.
Detailed description
This study is a sponsor-driven clinical trial (SIT) that aims to enroll patients who have undergone treatment for multivessel coronary artery disease using Genoss stents. The study involves collecting data on the clinical and surgical processes of patients and tracking the occurrence of clinical events. This prospective, multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions. As it is an observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants during the study registration period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GENOSS® DES Sirolimus Eluting Coronary Stent System | 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. |
Timeline
- Start date
- 2023-11-15
- Primary completion
- 2028-02-28
- Completion
- 2028-02-28
- First posted
- 2023-12-13
- Last updated
- 2025-10-06
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06168305. Inclusion in this directory is not an endorsement.