ENdothelial Healing Assessment With Novel Coronary tEchnology (ENHANCE)

May 1, 2017 updated by: Wan Azman Wan Ahmad, University of Malaya

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Coronary artery implanted with SYNERGY stent
One of the blocked coronary artery of a patient will received SYNERGY stent
Device: SYNERGY stent
Active Comparator: Coronary artery implanted with ABSORB scaffold
Another blocked coronary artery of the same patient will received ABSORB scaffold
Device: BVS ABSORB scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apposition and neointimal coverage on the stent and scaffold strut
Time Frame: 4 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apposition and neointimal coverage on the stent and scaffold strut
Time Frame: 12 months
Neointimal coverage on the stent or scaffold and their apposition using OCT and CAS at 12 month after stent implantation
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Collaborators

Boston Scientific Corporation
Kurume University

Investigators

  • Principal Investigator: Wan Azman Wan Ahmad, University Malaya Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

April 12, 2017

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISROTH10249

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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