Genoss DES in Patients With a High Risk of Ischemic Events (GENTLE Registry)
NCT ID: NCT05448625
Last Updated: 2025-11-25
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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COMPLETED
200 participants
OBSERVATIONAL
2022-05-26
2025-09-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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High Ischemic Group
1. Acute myocardial infarction (AMI)
2. ≥ 2 stents implanted
3. bifurcation lesion
4. Left main lesion
5. Lesion treated with rotational atherectomy
6. Chronic total occlusion (CTO) lesion
Genoss DES
The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.
Interventions
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Genoss DES
The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.
Eligibility Criteria
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Inclusion Criteria
* Subject has signed informed consent for data release
Exclusion Criteria
* Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media
* Pregnancy
* Subject with life expectancy less than 12 months
* Subject with cardiogenic shock
19 Years
ALL
No
Sponsors
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Severance Hospital
OTHER
Genoss Co., Ltd.
INDUSTRY
Yonsei University
OTHER
Responsible Party
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Yongcheol Kim
Clinical Associate Professor
Principal Investigators
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Deok-Kyu Cho, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yongin Severance Hopistal
Locations
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Yongin Severance Hospital
Yongin, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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9-2022-0014
Identifier Type: -
Identifier Source: org_study_id
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