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.

Not Applicable

• Conditions: Carotid Stenosis
• Interventions: Device: Filterwire EZ™; Device: MO.MA Ultra; Device: Stent Roadsaver®; Device: Carotid Wallstent

• Registration Number: NCT02915328
• 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-09
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-23
• Last Update Submitted: 2016-09-23
• Study First Posted: 2016-09-27
• Last Update Posted: 2016-09-27
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent Roadsaver® +Filterwire EZ™	Stent Roadsaver®	The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection
Carotid Wallstent + Filterwire EZ™	Filterwire EZ™	The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection
Stent Roadsaver® + MO.MA Ultra	MO.MA Ultra	The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection
Carotid Wallstent +MO.MA Ultra	Carotid Wallstent	The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection
Carotid Wallstent + Filterwire EZ™	Carotid Wallstent	The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection
Stent Roadsaver® + MO.MA Ultra	Stent Roadsaver®	The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection
Stent Roadsaver® +Filterwire EZ™	Filterwire EZ™	The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection
Carotid Wallstent +MO.MA Ultra	MO.MA Ultra	The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection

Primary Outcome Measures

Name	Time	Method
number of microembolization signals (MES) detected with transcranial doppler	intraprocedural	different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device retrieval/deflation

Secondary Outcome Measures

Name	Time	Method
6 month clinical follow up	6 month	all strokes, major and minor strokes, myocardial infarction
Doppler ultrasound assesment	day 2 or day 3, 1 month and 6 month	stent patency and long term restenosis of target carotid artery and target vessel external carotid artery
Clinical success	day 2 or day 3 and day 30 complication	all strokes, major and minor strokes, myocardial infarction

Trial Locations

Locations (1)

Centro Cardiologico Monzino, IRCCS; 🇮🇹 Milan, MI, Italy