NCT02915328UnknownNot Applicable
Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection.
Centro Cardiologico Monzino2 sites in 1 country100 target enrollmentStarted: April 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- number of microembolization signals (MES) detected with transcranial doppler
Study Overview
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.
The type of carotid stent and of cerebral protection are the two most important variables potentially affecting the rate of cerebral microembolization. So far there no consensus on the the best stent and cerebral protection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •significant, unilateral carotid artery stenosis with soft plaque defined as:
- •symptomatic patients: > 1.3 m/sec peak systolic velocity and > 50% diameter stenosis by Doppler ultrasound and < 60 hounsfield unit by CT angiography
- •asymptomatic patients > 2.5 m/sec peak systolic velocity and > 70% diameter stenosis by Doppler ultrasound and < 60 hounsfield unit by CT angiography
Exclusion Criteria
- •severe cerebral vasculopathy with cognitive impairment
- •contraindication to double antiplatelet treatment
- •controlateral carotid occlusion
Outcomes
Primary Outcomes
number of microembolization signals (MES) detected with transcranial doppler
Time Frame: intraprocedural
different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device retrieval/deflation
Secondary Outcomes
- 6 month clinical follow up(6 month)
- Doppler ultrasound assesment(day 2 or day 3, 1 month and 6 month)
- Clinical success(day 2 or day 3 and day 30 complication)
Investigators
Piero Montorsi
MD
Centro Cardiologico Monzino
Study Sites (2)
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