Efficacy and Safety of 1-year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-risk Procedure
NCT ID: NCT06075433
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2022-05-13
2027-12-31
Brief Summary
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Detailed Description
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The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of 1 year duration of DAPT after Genoss DES implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure from 9 sites in South Korea. The primary endpoint was a deviceoriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months. The key secondary endpoint was a patient-oriented composite endpoint (POCE), defined as a composite of all-cause death, any myocardial infarction, and any revascularization at 12 months.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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GENOSS Sirolimus Eluting Coronary Stent System
Patients with coronary artery disease treated with the GENOSS DES
\<Definition of a complex high-risk patients\>
1. Clinical factors
* Age 75 or older
* History of diabetes (those who have had diabetes in the past or are taking diabetes medication)
* History of chronic kidney disease (GFR \<60ml/min/1.73m2) or dialysis
* History of stroke
* History of coronary artery bypass graft
* Left ventricular dysfunction (LVEF \<40%)
* Severe valve disease
* Acute coronary syndrome with positive troponin levels
2. Lesion/procedure factors
* Left main lesion
* Chronic total occlusion
* Bifurcation lesion with branches larger than 2 mm
* Calcified lesion (moderate to severe calcified lesion)
* Restenosis lesion (in-stent restenosis)
* Multivessel PCI
* Three or more stents implanted (≥3 stents implanted)
* When the stent length of one lesion is more than 50 mm (total stent length \>50 mm in a lesion)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patients with coronary artery disease 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
2. Patients who are pregnant or planning to become pregnant
3. Patients with a life expectancy of less than 1 year
4. Patients participating in randomized controlled trials using other medical devices
5. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration (However, other stent insertions are allowed due to failure of GENOSS DES insertion)
19 Years
ALL
No
Sponsors
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Genoss Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Wonju Severance Christian Hospital
Wŏnju, Gangwon State, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIP-DS0501-14
Identifier Type: -
Identifier Source: org_study_id
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