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

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)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Drug-eluting Stent
• Intervention / Treatment: Device: Genoss DES

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, South Korea, 16995
      • Yongin Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High Ischemic Group; Acute myocardial infarction (AMI); ≥ 2 stents implanted; bifurcation lesion; Left main lesion; Lesion treated with rotational atherectomy; Chronic total occlusion (CTO) lesion	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Severance Hospital; Genoss Co., Ltd.
• Investigators: Principal Investigator: Deok-Kyu Cho, MD, PhD, Yongin Severance Hopistal

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Actual): May 14, 2025
• Study Completion (Actual): September 23, 2025

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 9-2022-0014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data set is available from the the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No