Efficacy and Safety of GENOSS SES in Patients With Coronary Artery Disease

NCT ID: NCT06841510

Last Updated: 2025-09-16

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-19

Study Completion Date

2025-11-30

Brief Summary

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Efficacy and Safety of GENOSS SES in patients with coronary artery disease

Detailed Description

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GENOSS SES

Conditions

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Coronary Arterial Disease (CAD)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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GENOSS Sirolimus Eluting Coronary Stent System

patients with coronary artery disease treated with GENOSS SES

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients of 19 and over
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

1. Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents
2. Patients who are pregnant or planning to become pregnant
3. Patients with a planned surgery to discontinue antiplatelet agents within 12 months
4. Patients with a life expectancy of less than 1 year
5. Patient with cardiogenic shock at the time of hospitalization and had a low chance of survival based on medical judgment.
6. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration
7. Patients participating in randomized controlled trials using other medical devices
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genoss Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CIP-DS0501-09

Identifier Type: -

Identifier Source: org_study_id

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