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

Yonsei University

Status: Completed

Conditions: Coronary Artery Disease; Drug-eluting Stent

Treatments: Device: Genoss DES

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05448625

9-2022-0014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

High Ischemic Group

Description:

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

Treatment:

Device: Genoss DES