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 Monzino

Status: Unknown

Conditions: Carotid Stenosis

Treatments: Device: Carotid Wallstent; Device: Filterwire EZ™; Device: Stent Roadsaver®; Device: MO.MA Ultra

Study type: Interventional

Funder types: Other

Identifiers

NCT02915328

R323/15 - CCM334

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Stent Roadsaver® +Filterwire EZ™

Experimental group

Description:

The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection

Treatment:

Device: Stent Roadsaver®

Device: Filterwire EZ™

Stent Roadsaver® + MO.MA Ultra

Experimental group

Description:

The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection

Treatment:

Device: Stent Roadsaver®

Device: MO.MA Ultra

Carotid Wallstent +MO.MA Ultra

Experimental group

Description:

The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection

Treatment:

Device: Carotid Wallstent

Device: MO.MA Ultra

Carotid Wallstent + Filterwire EZ™

Experimental group

Description:

The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection

Treatment:

Device: Carotid Wallstent

Device: Filterwire EZ™