Carotid Stenting in Patients With High Risk Carotid Stenosis ("Soft Plaque")
Not Applicable
Completed
- Conditions
- Carotid Stenosis
- Interventions
- Device: carotid stenting with MOMADevice: Carotid stenting with filter wire EZ
- Registration Number
- NCT01274676
- Lead Sponsor
- Centro Cardiologico Monzino
- Brief Summary
Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The intra and/or postprocedural cerebral embolization remains the most frequent complication. Thanks to the systematic use of cerebral protection systems, these complications have reduced.A debate concerning which cerebral protective device should be more effective is still ongoing.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Inclusion Criteria
-patients with monolateral, significant, soft carotid stenosis
Exclusion Criteria
- patients with controlateral carotid occlusion
- patients with critic stenosis of the external carotid
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description carotid stenting with MOMA carotid stenting with MOMA - Carotid stenting with filter wire EZ Carotid stenting with filter wire EZ -
- Primary Outcome Measures
Name Time Method number of Microembolization signals (MES) detected with transcranal doppler 6 different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device tetruieval/deflation
- Secondary Outcome Measures
Name Time Method Clinical success In hospital and 30 days Assesment of any clinical and neurological complication (death, any stroke, TIA; myocardial infarction).
Trial Locations
- Locations (1)
Centro Cardiologico Monzino, IRCCS
🇮🇹Milan, Italy