ENdothelial Healing Assessment With Novel Coronary tEchnology (ENHANCE)

University of Malaya

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: BVS ABSORB scaffold; Device: SYNERGY stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02747199

ISROTH10249

Details and patient eligibility

About

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

Full 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%.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Coronary artery implanted with SYNERGY stent

Active Comparator group

Description:

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

Treatment:

Device: SYNERGY stent

Coronary artery implanted with ABSORB scaffold

Active Comparator group

Description:

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

Treatment:

Device: BVS ABSORB scaffold