Completed

Sirolimus-eluting Stents for High-risk Ischemic Events

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Study Aim

This study observes the outcomes of using sirolimus-eluting stents in patients at high risk for ischemic events, focusing on cardiac death, myocardial infarction, and the need for further revascularization.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 19 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2022
See protocol details

Summary

Principal SponsorYonsei University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 26, 2022

Actual date on which the first participant was enrolled.

This study focuses on evaluating a new type of heart stent called the Sirolimus-eluting Biodegradable Abluminal Coating Stent in patients who are at high risk for serious heart-related issues, like ischemic events, after undergoing procedures such as percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). These patients often have complex forms of coronary artery disease, which makes them more vulnerable to problems. The study aims to gather information about how well these stents work in reducing risks for patients with such complicated heart conditions, addressing a gap as there is limited data on this specific type of stent. Participants in this observational study will receive the Genoss stents as part of their treatment. The study will closely monitor how effective these stents are by looking at outcomes like cardiac death, heart attacks related to the treated vessels, and the need for additional procedures if the treated area narrows again. Since the study is observational, it involves watching and recording what happens to participants over time without altering their standard medical care. This approach will help determine how safe and effective the stents are in real-world settings for those with high-risk heart conditions.

Official TitleSafety 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)
NCT05448625
Principal SponsorYonsei University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial Ischemia

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Yongin Severance Hospital

Yongin, South KoreaOpen Yongin Severance Hospital in Google Maps
CompletedOne Study Center
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