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)

University of Malaya0 sites13 target enrollmentAugust 2015

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: University of Malaya
Enrollment: 13
Primary Endpoint: Apposition and neointimal coverage on the stent and scaffold strut
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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%.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

April 12, 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Malaya

Responsible Party

Principal Investigator

Wan Azman Wan Ahmad

Professor Dr

University of Malaya

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)