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

March 12, 2024 updated by: Yongcheol Kim, Yonsei University

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yongcheol Kim, MD, Phd
  • Phone Number: +82-031-5189-8967
  • Email: yongcheol@yuhs.ac

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Yongin, Gyeonggi-do, Korea, Republic of, 16995
        • Recruiting
        • Yongin Severance Hospital
        • Sub-Investigator:
          • Oh-Hyun Lee
        • Sub-Investigator:
          • Ji Woong Roh
        • Sub-Investigator:
          • Eui Im
        • Contact:
        • Principal Investigator:
          • Deok-Kyu Cho
        • Sub-Investigator:
          • Yongcheol Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)
Time Frame: 12 months
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
Time Frame: 12 months
A composite rate of all death, all myocardial infarction, and all revascularization
12 months
Number of participants with all death
Time Frame: 12 months
A composite rate of all death
12 months
Number of participants with cardiac death
Time Frame: 12 months
A composite rate of cardiac death
12 months
Number of participants with non-cardiac death
Time Frame: 12 months
A composite rate of non-cardiac death
12 months
Number of participants with all myocardial infarction
Time Frame: 12 months
A composite rate of all myocardial infarction
12 months
Number of participants with target-vessel myocardial infarction (TV-MI)
Time Frame: 12 months
A composite rate of target-vessel myocardial infarction (TV-MI)
12 months
Number of participants with all revascularization
Time Frame: 12 months
A composite rate of all revascularization
12 months
Number of participants with ischemic driven target lesion revascularization (ID-TLR)
Time Frame: 12 months
A composite rate of ischemic driven target lesion revascularization (ID-TLR)
12 months
Number of participants with stent thrombosis
Time Frame: Within 24 hours, 30 days, 12 months
A composite rate of stent thrombosis
Within 24 hours, 30 days, 12 months
Number of participants with non-ischemic targeted lesion perfusion
Time Frame: 12 months
A composite rate of non-ischemic targeted lesion perfusion
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

Severance Hospital
Genoss Co., Ltd.

Investigators

  • Principal Investigator: Deok-Kyu Cho, MD, PhD, Yongin Severance Hopistal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2026

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 (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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