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

Recruiting

• Conditions: Drug-eluting Stent; Coronary Artery Disease
• Interventions: Device: Genoss DES

• Registration Number: NCT05448625
• Lead Sponsor: Yonsei University

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.

Detailed Description

It is known that ischemic events after percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) increase as the anatomical, physiological, or functional complexity of coronary artery disease increases. Recently, the concept of complex higher-risk and clinically indented procedure (CHIP) has been proposed, which includes patients with various medical conditions, patients with various heart conditions, and patients with technically complex PCI. Until now, Genoss stents have no data on the evaluation of stents in patients with coronary artery disease and high ischemic features.

Study Timeline

• Study Start: 2022-05-26
• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-07-02
• Study First Posted: 2022-07-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High Ischemic Group	Genoss DES	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

Primary Outcome Measures

Name	Time	Method
Number of participants with device-oriented compopsite endpoint (TLF)	12 months	A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR)

Secondary Outcome Measures

Name	Time	Method
Number of participants with patient-oriented composite endpoint	12 months	A composite rate of all death, all myocardial infarction, and all revascularization
Number of participants with all revascularization	12 months	A composite rate of all revascularization
Number of participants with all myocardial infarction	12 months	A composite rate of all myocardial infarction
Number of participants with cardiac death	12 months	A composite rate of cardiac death
Number of participants with non-cardiac death	12 months	A composite rate of non-cardiac death
Number of participants with non-ischemic targeted lesion perfusion	12 months	A composite rate of non-ischemic targeted lesion perfusion
Number of participants with all death	12 months	A composite rate of all death
Number of participants with target-vessel myocardial infarction (TV-MI)	12 months	A composite rate of target-vessel myocardial infarction (TV-MI)
Number of participants with ischemic driven target lesion revascularization (ID-TLR)	12 months	A composite rate of ischemic driven target lesion revascularization (ID-TLR)
Number of participants with stent thrombosis	Within 24 hours, 30 days, 12 months	A composite rate of stent thrombosis

Trial Locations

Locations (1)

Yongin Severance Hospital; 🇰🇷 Yongin, Gyeonggi-do, Korea, Republic of