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OpenTrials
Completed

NCT Number: NCT02747199

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is 20 years old or older
  • Subject or legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
  • Subject must have evidence of myocardial ischemia (eg stable or unstable angina, silent ischemia) suitable for elective PCI
  • Significant narrowing of at least 70% stenosis of de novo lesion (QCA or visual estimation) in 2 different native coronary arteries.
  • Subject is eligible for to undergo OCT and CAS examination at 4 months and 12 months after stent or scaffold implantation.
  • 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

  • Subject had an acute myocardial infarction (STEMI or NSTEMI) within 24 hours of the index procedure
  • Subject has known left ventricular ejection fraction (LVEF) < 30%
  • Subject is receiving hemodialysis
  • Target vessel were treated by PCI within 12 months
  • Target lesion is located within a saphenous vein graft or an arterial graft
  • Target lesion is located in ostium
  • Target lesion is located highly tortuous equal to or greater than 60 degrees
  • Target lesion with TIMI flow 0 (total occlusion)

Treatment and study plan

Synergy Stent

Device

BVS ABSORB scaffold

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Collaborators

  • Boston Scientific Corporation
  • Kurume University

Registry information

Official study 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)

Acronym: ENHANCE

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 21, 2016
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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