Genoss DES in Patients With a High Risk of Ischemic Events (GENTLE Registry)

NCT05448625 | Completed

• 1 other identifier: 9-2022-0014
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study to evaluate the long-term effect and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease with high ischemic features.

Conditions

Drug-eluting Stent; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants with device-oriented compopsite endpoint (TLF)

  A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR)

  12 months

Secondary Outcomes (11)

• Number of participants with patient-oriented composite endpoint

  12 months

• Number of participants with all death

  12 months

• Number of participants with cardiac death

  12 months

• Number of participants with non-cardiac death

  12 months

• Number of participants with all myocardial infarction

  12 months

Study Arms (1)

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

Device: Genoss DES

Interventions

Genoss DES DEVICE

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.

High Ischemic Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

You may qualify if:

• Subject is ≥ 19 years
• Subject has signed informed consent for data release

You may not qualify if:

• Subject did not sign informed consent for data release
• 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

Sponsors & Collaborators

• Yonsei University: lead
• Severance Hospital: collaborator
• Genoss Co., Ltd.: collaborator

Study Sites (1)

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Deok-Kyu Cho, MD, PhD

  Yongin Severance Hopistal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 7, 2022
• Study Start: May 26, 2022
• Primary Completion: May 14, 2025
• Study Completion: September 23, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)