ENdothelial Healing Assessment With Novel Coronary tEchnology

Coronary Artery Disease Clinical Trial

— ENHANCE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747199
• Other study ID #: ISROTH10249
• Status: Completed
• Phase: N/A
• First received: April 19, 2016
• Last updated: May 1, 2017
• Start date: August 2015
• Est. completion date: April 12, 2017

Study information

• Verified date: May 2017
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 12, 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• SYNERGY stent

• BVS ABSORB scaffold

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Malaya	Boston Scientific Corporation, Kurume University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apposition and neointimal coverage on the stent and scaffold strut	Neointimal coverage on the stent and scaffold strut and their apposition using OCT and CAS at 4 month after the stent implantation.	4 months
Secondary	Apposition and neointimal coverage on the stent and scaffold strut	Neointimal coverage on the stent or scaffold and their apposition using OCT and CAS at 12 month after stent implantation	12 months