ENdothelial Healing Assessment With Novel Coronary tEchnology

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02747199

Acronym

ENHANCE

Enrollment

Registered

2016-04-21

Start date

2015-08-31

Completion date

2017-04-12

Last updated

2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

SYNERGY, Neointimal formation, OCT, coronary angioscopy, coronary artery disease

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%.

Interventions

DEVICEBVS ABSORB scaffold

DEVICESYNERGY stent

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026