Trials / Completed
CompletedNCT02747199
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- University of Malaya · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SYNERGY stent | |
| DEVICE | BVS ABSORB scaffold |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2016-07-01
- Completion
- 2017-04-12
- First posted
- 2016-04-21
- Last updated
- 2017-05-04
Source: ClinicalTrials.gov record NCT02747199. Inclusion in this directory is not an endorsement.