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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

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ClinicalTrials.gov Identifier: NCT02796157
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold Device: PCI with Xience everolimus-eluting metallic stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: absorb arm
PCI with Absorb everolimus-eluting bioresorbable vascular scaffold
Device: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold
Patients allocated to this arm will undergone PCI with Absorb everolimus-eluting bioresorbable vascular scaffold. It will be allowed to used multiple stents for a long coronary lesion.

Experimental: Xience arm
PCI with Xience everolimus-eluting metallic stent
Device: PCI with Xience everolimus-eluting metallic stent
Patients allocated to this arm will undergone PCI with Xience everolimus-eluting metallic stent. It will be allowed to used multiple stents for a long coronary lesion.




Primary Outcome Measures :
  1. Incidence of composite of major adverse cardiovascular events [ Time Frame: 1 year after PCI ]
    Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796157


Locations
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Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: MYEONG-KI HONG, MD    82-2-2228-8458    MKHONG61@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02796157     History of Changes
Other Study ID Numbers: 1-2016-0025
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yonsei University:
bioresorbable vascular scaffold, drug eluting stent, coronary artery disease

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents