ENdothelial Healing Assessment With Novel Coronary tEchnology

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: SYNERGY stent; Device: BVS ABSORB scaffold

• Registration Number: NCT02747199
• Lead Sponsor: University of Malaya

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%.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-21
• Primary Completion: 2016-07
• Study Completion: 2017-04-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary artery implanted with SYNERGY stent	SYNERGY stent	One of the blocked coronary artery of a patient will received SYNERGY stent
Coronary artery implanted with ABSORB scaffold	BVS ABSORB scaffold	Another blocked coronary artery of the same patient will received ABSORB scaffold

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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