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CompletedNCT02747199ENHANCEUpdated May 4, 2017

ENdothelial Healing Assessment With Novel Coronary tEchnology

An interventional study of SYNERGY stent and BVS ABSORB scaffold in Coronary Artery Disease, sponsored by University of Malaya. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-04.

Sponsored by University of Malaya · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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%.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • SYNERGY
  • Neointimal formation
  • OCT
  • coronary angioscopy
  • coronary artery disease
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 13 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • 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

Interventions

  • DeviceSYNERGY stent
  • DeviceBVS ABSORB scaffold
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 months

Secondary outcomes

  1. 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

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02747199
Lead sponsor
University of Malaya
Collaborators
Boston Scientific Corporation, Kurume University
Responsible party
Wan Azman Wan Ahmad (Professor Dr, University of Malaya) — Principal investigator
First posted
Apr 21, 2016
Start date
Aug 2015
Primary completion
Jul 2016
Completion
Apr 12, 2017
Last update
May 4, 2017

Study contacts

Wan Azman Wan Ahmad
principal investigator · University Malaya Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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