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ENdothelial Healing Assessment With Novel Coronary tEchnology (ENHANCE)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SYNERGY stent
BVS ABSORB scaffold
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring SYNERGY, Neointimal formation, OCT, coronary angioscopy, coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is 20 years old or older
  2. Subject or legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
  3. Subject must have evidence of myocardial ischemia (eg stable or unstable angina, silent ischemia) suitable for elective PCI
  4. Significant narrowing of at least 70% stenosis of de novo lesion (QCA or visual estimation) in 2 different native coronary arteries.
  5. Subject is eligible for to undergo OCT and CAS examination at 4 months and 12 months after stent or scaffold implantation.
  6. Subject is able to take dual anti-platelet therapy up to one year following the index procedure and anticoagulants prior/during the index procedure

Exclusion Criteria:

  1. Subject had an acute myocardial infarction (STEMI or NSTEMI) within 24 hours of the index procedure
  2. Subject has known left ventricular ejection fraction (LVEF) < 30%
  3. Subject is receiving hemodialysis
  4. Target vessel were treated by PCI within 12 months
  5. Target lesion is located within a saphenous vein graft or an arterial graft
  6. Target lesion is located in ostium
  7. Target lesion is located highly tortuous equal to or greater than 60 degrees
  8. Target lesion with TIMI flow 0 (total occlusion)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Coronary artery implanted with SYNERGY stent

    Coronary artery implanted with ABSORB scaffold

    Arm Description

    One of the blocked coronary artery of a patient will received SYNERGY stent

    Another blocked coronary artery of the same patient will received ABSORB scaffold

    Outcomes

    Primary Outcome Measures

    Apposition and neointimal coverage on the stent and scaffold strut
    Neointimal coverage on the stent and scaffold strut and their apposition using OCT and CAS at 4 month after the stent implantation.

    Secondary Outcome Measures

    Apposition and neointimal coverage on the stent and scaffold strut
    Neointimal coverage on the stent or scaffold and their apposition using OCT and CAS at 12 month after stent implantation

    Full Information

    First Posted
    April 19, 2016
    Last Updated
    May 1, 2017
    Sponsor
    University of Malaya
    Collaborators
    Boston Scientific Corporation, Kurume University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02747199
    Brief Title
    ENdothelial Healing Assessment With Novel Coronary tEchnology
    Acronym
    ENHANCE
    Official Title
    Comparison Between SYNERGY™ vs. Bioresorbable Vascular Scaffold (BVS) ABSORB Neointimal Formation Assessed by (Optical Coherence Tomography) OCT and Coronary Angioscopy (CAS) Evaluation (The ENHANCE Study - ENdothelial Healing Assessment With Novel Coronary tEchnology)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    April 12, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Malaya
    Collaborators
    Boston Scientific Corporation, Kurume University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a prospective, non-randomized, single center clinical trial to assess neointimal coverage on the stent or scaffold strut and apposition of SYNERGY™ and ABSORB in minimum of 12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using OCT and CAS
    Detailed Description
    All of the subject will received SYNERGY™ stent in one of the blocked coronary artery and ABSORB scaffold strut in the other artery. All subjects must have 2 coronary arteries stenosis of more than 70%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease
    Keywords
    SYNERGY, Neointimal formation, OCT, coronary angioscopy, coronary artery disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Coronary artery implanted with SYNERGY stent
    Arm Type
    Active Comparator
    Arm Description
    One of the blocked coronary artery of a patient will received SYNERGY stent
    Arm Title
    Coronary artery implanted with ABSORB scaffold
    Arm Type
    Active Comparator
    Arm Description
    Another blocked coronary artery of the same patient will received ABSORB scaffold
    Intervention Type
    Device
    Intervention Name(s)
    SYNERGY stent
    Intervention Type
    Device
    Intervention Name(s)
    BVS ABSORB scaffold
    Primary Outcome Measure Information:
    Title
    Apposition and neointimal coverage on the stent and scaffold strut
    Description
    Neointimal coverage on the stent and scaffold strut and their apposition using OCT and CAS at 4 month after the stent implantation.
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Apposition and neointimal coverage on the stent and scaffold strut
    Description
    Neointimal coverage on the stent or scaffold and their apposition using OCT and CAS at 12 month after stent implantation
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject is 20 years old or older Subject or legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements. Subject must have evidence of myocardial ischemia (eg stable or unstable angina, silent ischemia) suitable for elective PCI Significant narrowing of at least 70% stenosis of de novo lesion (QCA or visual estimation) in 2 different native coronary arteries. Subject is eligible for to undergo OCT and CAS examination at 4 months and 12 months after stent or scaffold implantation. Subject is able to take dual anti-platelet therapy up to one year following the index procedure and anticoagulants prior/during the index procedure Exclusion Criteria: Subject had an acute myocardial infarction (STEMI or NSTEMI) within 24 hours of the index procedure Subject has known left ventricular ejection fraction (LVEF) < 30% Subject is receiving hemodialysis Target vessel were treated by PCI within 12 months Target lesion is located within a saphenous vein graft or an arterial graft Target lesion is located in ostium Target lesion is located highly tortuous equal to or greater than 60 degrees Target lesion with TIMI flow 0 (total occlusion)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wan Azman Wan Ahmad
    Organizational Affiliation
    University Malaya Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    ENdothelial Healing Assessment With Novel Coronary tEchnology

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