Trials / Completed
CompletedNCT01543373
Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS
Randomized Comparison Between a DES and a BMS to Assess Neointimal Coverage by OCT Evaluation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- CID - Carbostent & Implantable Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Amphilimus Eluting Stent | Sirolimus formulated coronary eluting stent |
| DEVICE | Bare Metal Stent | Bare metal coronary stent |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2013-08-01
- Completion
- 2014-04-01
- First posted
- 2012-03-05
- Last updated
- 2018-04-30
Locations
6 sites across 2 countries: Italy, Netherlands
Source: ClinicalTrials.gov record NCT01543373. Inclusion in this directory is not an endorsement.