A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions
Not Applicable
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT02796157
- Lead Sponsor
- Yonsei University
- Brief Summary
PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary intervention in long lesions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 950
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of composite of major adverse cardiovascular events 1 year after PCI Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine🇰🇷Seoul, Korea, Republic of