Clinical trial NCT05448625: Genoss DES in Patients With a High Risk of Ischemic Events (GENTLE Registry)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug-eluting Stent
Coronary Artery Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Severance Hospital
name: Genoss Co., Ltd.
First posted: 2022-07-07
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with device-oriented compopsite endpoint (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with patient-oriented composite endpoint
timeFrame: 12 months
measure: Number of participants with all death
timeFrame: 12 months
measure: Number of participants with cardiac death
timeFrame: 12 months
measure: Number of participants with non-cardiac death
timeFrame: 12 months
measure: Number of participants with all myocardial infarction
timeFrame: 12 months
measure: Number of participants with target-vessel myocardial infarction (TV-MI)
timeFrame: 12 months
measure: Number of participants with all revascularization
timeFrame: 12 months
measure: Number of participants with ischemic driven target lesion revascularization (ID-TLR)
timeFrame: 12 months
measure: Number of participants with stent thrombosis
timeFrame: Within 24 hours, 30 days, 12 months
measure: Number of participants with non-ischemic targeted lesion perfusion
timeFrame: 12 months
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
Study officials:
affiliation: Yongin Severance Hopistal
name: Deok-Kyu Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: