Trials / Completed
CompletedNCT00798512
Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device.
DESERVE: Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device. A Prospective, Multicenter Study.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- Invatec S.p.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to detect new ischemic lesions after carotid artery stenting (with the Cristallo Ideale stent), in patients with high grade carotid artery stenosis, by diffusion-weighted magnetic resonance imaging (DW-MRI), using the endovascular proximal flow blockage (Mo.Ma device) for cerebral protection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Carotid artery stenting | The MO.MA is a cerebral protection catheter based on the proximal flow blockage concept which is achieved by endovascular clamping of Common Carotid Artery (CCA) and External Carotid Artery (ECA). The MO.MA proximal flow blockage cerebral protection device is indicated to be used in patients eligible for carotid angioplasty and/or the carotid bifurcation and is aimed to prevent brain embolism during the stenting procedure. For the purpose of this study the Cristallo Ideale™ Carotid Stent System (Invatec S.R.L. Roncadelle, Italy) will be exclusively used. Cristallo Ideale™ consists of a carotid dedicated self-expanding stent pre-mounted on a rapid exchange delivery catheter. The stent platform is made of a Nitinol alloy and characterized by a hybrid design with closed cell in the central zone and open cell in both end zones (proximal and distal). |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2010-12-01
- Completion
- 2011-03-01
- First posted
- 2008-11-26
- Last updated
- 2016-03-15
Locations
6 sites across 3 countries: Germany, Italy, Poland
Source: ClinicalTrials.gov record NCT00798512. Inclusion in this directory is not an endorsement.