Trials / Unknown
UnknownNCT02946320
Optimal Predilatation Technique for BVS Implantation
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Cardiology Center Agel · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the optimal way of predilatation for BVS implantation.
Detailed description
Randomized, single-center study. Forty-five patients with intended BVS implantation will be randomized in ratio of 1:1:1 to different predilatation strategies(non-compliant balloon/Emerge NC™, Boston Scientific, cutting balloon/Flexitome™, scoring balloon/Scoroflex™,Orbus). Predilatation is intended to be done in a vessel:balloon ratio of 1:1. If the device is not able enter the lesion, it will be replaced with a conventional semicompliant balloon with the same predilatation strategy (a vessel:balloon ratio of 1:1) After a successful predilatation, the BVS (Absorb™, Abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (Emerge NC™, BSCI). The MLA of the Absorb stent will be evaluated with optical coherence tomography (OPTIS, St.Jude).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Predilatation with non-compliant balloon | Coronary artery stenosis is dilated before BVS implantation with the use of non-compliant balloon (standard procedure). Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1) |
| DEVICE | Predilatation with scoring balloon (Scoroflex) | Coronary artery stenosis is dilated before BVS implantation with the use of scoring balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1) |
| DEVICE | Predilatation with cutting balloon (Flextome) | Coronary artery stenosis is dilated before BVS implantation with the use of cutting balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1) |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2017-03-01
- Completion
- 2017-03-01
- First posted
- 2016-10-27
- Last updated
- 2016-10-27
Source: ClinicalTrials.gov record NCT02946320. Inclusion in this directory is not an endorsement.