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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Number of participants with device-oriented compopsite endpoint (TLF)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Number of participants with target-vessel myocardial infarction (TV-MI)(12 months)
- Number of participants with all myocardial infarction(12 months)
- Number of participants with all revascularization(12 months)
- Number of participants with ischemic driven target lesion revascularization (ID-TLR)(12 months)
- Number of participants with patient-oriented composite endpoint(12 months)
- Number of participants with all death(12 months)
- Number of participants with cardiac death(12 months)
- Number of participants with non-cardiac death(12 months)
- Number of participants with stent thrombosis(Within 24 hours, 30 days, 12 months)
- Number of participants with non-ischemic targeted lesion perfusion(12 months)
- Number of participants with Non target vessel myocardial infarction(12 months)
Investigators
Yongcheol Kim
Clinical Associate Professor
Yonsei University