KCT0002900
Completed
未知
A randomized comparison of clinical outcomes between everolimus-eluting bioresorbable vascular scaffold versus everolimus-eluting metallic stent in long coronary lesions
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 341
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
At 12 months, the primary endpoint events occurred in 2 patients (1.2%) in the BVS group and in 4 patients (2.4%) in the EES group (hazard ratio [HR]=0.49, 95% confidence interval [CI]=0.09-2.67, P=0.398).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 19\-85 years
- •Patients with ischemic heart disease requiring PCI
- •Significant coronary de novo lesion (stenosis \>50% by quantitative angiographic analysis) requiring stent \=28 mm in length based on angiographic estimation
- •Reference vessel diameter of 2\.5 to 3\.75 mm by operator assessment
Exclusion Criteria
- •Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support
- •Complex coronary morphology including left main disease and bifurcation lesion requiring two\-stent technique
- •Contraindication or hypersensitivity to anti\-platelet agents or contrast media
- •Treated with any metallic stent or BVS within 3 months at other vessel
- •Cardiogenic shock
- •Left ventricular ejection fraction \<40%
- •Pregnant women or women with potential childbearing
- •Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- •Inability to understand or read the informed content
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Comparison of clinical efficacy and safety of weekly GLP-1 receptor agonists dulaglutide and semaglutideType 2 diabetesJPRN-UMIN000044264Kawasai Medical School120
Completed
Phase 2
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C InfectionHepatitis C, ChronicNCT02765490Janssen Research & Development, LLC365
Completed
Phase 2
Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV MelanomaMelanomaNCT00289640Bristol-Myers Squibb210
Completed
Phase 2
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative ColitisModerate to Severe Ulcerative ColitisNCT04090411Hoffmann-La Roche246
Completed
Phase 3
A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)Osteoporosis, PostmenopausalNCT00092040Organon and Co936