ENHANCE: ENdothelial Healing Assessment With Novel Coronary tEchnology

Sponsor

University of Malaya (Other)

Overall Status

Completed

CT.gov ID

NCT02747199

Collaborator

Boston Scientific Corporation (Industry), Kurume University (Other)

Enrollment

Arms

20.4

Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: SYNERGY stent Device: BVS ABSORB scaffold	N/A

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%.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Apr 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Coronary artery implanted with SYNERGY stent One of the blocked coronary artery of a patient will received SYNERGY stent	Device: SYNERGY stent
Active Comparator: Coronary artery implanted with ABSORB scaffold Another blocked coronary artery of the same patient will received ABSORB scaffold	Device: BVS ABSORB scaffold

Arm

Intervention/Treatment

Active Comparator: Coronary artery implanted with SYNERGY stent

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

Device: SYNERGY stent

Active Comparator: Coronary artery implanted with ABSORB scaffold

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

Device: BVS ABSORB scaffold

Outcome Measures

Primary Outcome Measures

Apposition and neointimal coverage on the stent and scaffold strut [4 months]
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 [12 months]
Neointimal coverage on the stent or scaffold and their apposition using OCT and CAS at 12 month after stent implantation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)