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
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
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)
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
NCT ID
NCT02747199
First Posted
April 19, 2016
Last Updated
May 1, 2017
Sponsor
University of Malaya
Collaborators
Boston Scientific Corporation, Kurume University
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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