Percutaneous Coronary InterventionGENOSS-MVNCT06168305
Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease
An observational study of Percutaneous Coronary Intervention and Multivessel Coronary Artery Disease, run by Genoss Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Multivessel Coronary Artery Disease
- What is being tested?
- GENOSS® DES Sirolimus Eluting Coronary Stent System
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2023to 28 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Study population: Patients with multivessel coronary artery disease (MVCAD) who underwent percutaneous coronary intervention using GENOSS® DES
<Inclusion Criteria>
- Adults over 19 years of age
- Subjects with multivessel coronary artery disease (MVCAD) (However, subject registration is possible even if the treatment area is restenosis or recurrent lesion, including new lesions)
- Subjects who underwent percutaneous coronary intervention (PCI) with GENOSS® DES
- Research subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and give written consent in the informed consent form. (However, in the case of foreigners, only those who can speak Korean fluently and understand Korean documents such as the consent form are included.)
<Exclusion Criteria>
- Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded)
- When balloon angioplasty is performed on a stenotic area, the balloon cannot be expanded.
- Those whose remaining life expectancy is less than 1 year
- Expecting to become pregnant, pregnant or lactating woman
- The patient was admitted to the hospital due to cardiogenic shock and was predicted to have a low chance of survival based on medical judgment.
Subject
- If the researcher determines that the product is not suitable for this clinical study or may increase the risks associated with participation in the study.
- Foreigners who cannot speak Korean fluently and have difficulty understanding Korean documents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Effectiveness of GENOSS® DES (Sirolimus-eluting Coronary Stent System) in Patients With Multivessel Coronary Artery Disease (MVCAD): A Multicenter, Prospective, Observational Study
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.
Read the 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.
- Being tested
- GENOSS® DES Sirolimus Eluting Coronary Stent System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GENOSS® DES Sirolimus Eluting Coronary Stent SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4] | Patients with multivessel coronary artery disease (MVCAD) who underwent percutaneous coronary intervention using GENOSS® DES Receives: Device: GENOSS® DES Sirolimus Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)
Measured: at 12 months after the procedure
Secondary outcomes (10)
Major adverse cardiac events (MACE)
The composite end point of death, myocardial infarction, target lesion revascularization
Measured: at 12 months after the procedure
Cardiac death
Measured: at 12 months after the procedure
Non-cardiac death
Measured: at 12 months after the procedure
TV-MI (target vessel-myocardial infarction)
Measured: at 12 months after the procedure
Non-target vessel myocardial infarction
Measured: at 12 months after the procedure
ID-TVR (ischemia-driven target vessel revascularization)
Measured: at 12 months after the procedure
Non-ischemia driven target vessel revascularization
Measured: at 12 months after the procedure
Incidence rate of acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year
Acute (within 24 hours), subacute (within 30 days), late (within 1 year)
Measured: within 24 hours, 30 days, 1 year
Device success
The clinical device is successfully delivered to the target lesion, inflated normally, and recovered intact.
Measured: during the procedure
Procedure success
When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedural death, myocardial infarction, or revascularization during the hospitalization period.
Measured: during the hospitalization period (up to 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start15 Nov 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Genoss Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genoss Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168305
- Sponsor's protocol ID
- 2023GR0399
- Acronym
- GENOSS-MV
- Status last verified
- Sep 2025
- First submitted
- 28 Nov 2023
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of GENOSS® DES (Sirolimus-eluting Coronary Stent System) in Patients With Multivessel Coronary Artery Disease (MVCAD): A Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06168305
- Acronym / sponsor ID
- GENOSS-MV / 2023GR0399
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Genoss Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4] | – | Device: GENOSS® DES Sirolimus Eluting Coronary Stent SystemPatients with multivessel coronary artery disease (MVCAD) who underwent percutaneous coronary intervention using GENOSS® DES |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with multivessel coronary artery disease (MVCAD) who underwent percutaneous coronary intervention using GENOSS® DES
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GENOSS® DES Sirolimus Eluting Coronary Stent SystemThe 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. | Device | GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4] |
Primary outcome
Target Lesion Failure (TLF)
Time frame: at 12 months after the procedure
The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)
10 secondary outcomes
Major adverse cardiac events (MACE)
Time frame: at 12 months after the procedure
Cardiac death
Time frame: at 12 months after the procedure
Non-cardiac death
Time frame: at 12 months after the procedure
TV-MI (target vessel-myocardial infarction)
Time frame: at 12 months after the procedure
Non-target vessel myocardial infarction
Time frame: at 12 months after the procedure
ID-TVR (ischemia-driven target vessel revascularization)
Time frame: at 12 months after the procedure
Non-ischemia driven target vessel revascularization
Time frame: at 12 months after the procedure
Incidence rate of acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year
Time frame: within 24 hours, 30 days, 1 year
Device success
Time frame: during the procedure
Procedure success
Time frame: during the hospitalization period (up to 3 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Percutaneous Coronary Intervention
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention and Multivessel Coronary Artery Disease, run by Genoss Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: at 12 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.