Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments synergy stent, bvs absorb scaffold
Phase phase 4
Sponsor University of Malaya
Collaborator Boston Scientific Corporation
Start date August 2015
End date July 2016
Trial size 13 participants
Trial identifier NCT02747199, ISROTH10249

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
One of the blocked coronary artery of a patient will received SYNERGY stent
synergy stent
(Active Comparator)
Another blocked coronary artery of the same patient will received ABSORB scaffold
bvs absorb scaffold

Primary Outcomes

Measure
Apposition and neointimal coverage on the stent and scaffold strut
time frame: 4 months

Secondary Outcomes

Measure
Apposition and neointimal coverage on the stent and scaffold strut
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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)
Principal investigator Wan Azman Wan Ahmad
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%.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Malaya.