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

Coronary Artery Disease Clinical Trial

Official title:

Safety and Efficacy of Sirolimus-eluting Biodegradable Abluminal Coating Stents in Patients With a High Risk of Ischemic Events: a Single-center, Prospective, Observational Trial (GENTLE Registry)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05448625
• Other study ID #: 9-2022-0014
• Status: Recruiting
• Start date: May 26, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: Yongcheol Kim, MD, Phd
• Phone: +82-031-5189-8967
• Email: yongcheol[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Drug-eluting Stent

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Yongin Severance Hospital	Yongin	Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Yonsei University	Genoss Co., Ltd., Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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