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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02915328

Enrollment

100

Registered

2016-09-27

Start date

2016-04-30

Completion date

2018-04-30

Last updated

2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Stenosis

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.

Interventions

DEVICEFilterwire EZ™

DEVICEMO.MA Ultra

DEVICEStent Roadsaver®

DEVICECarotid Wallstent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Clinical success	day 2 or day 3 and day 30 complication	all strokes, major and minor strokes, myocardial infarction
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

Countries

Italy

Contacts

Primary ContactPiero Montorsi, MD

piero.montorsi@ccfm.it0039 0258002

Backup ContactStefano Galli, MD

stefano.galli@ccfm.it0039 02 58002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026