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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
NameTimeMethod
Incidence of composite of major adverse cardiovascular events1 year after PCI

Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)

Secondary Outcome Measures
NameTimeMethod

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

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