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.

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 Overview

• Status: Unknown
• Conditions: Carotid Stenosis
• Intervention / Treatment: Device: Filterwire EZ™; Device: Stent Roadsaver®; Device: MO.MA Ultra; Device: Carotid Wallstent

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Piero Montorsi, MD; Phone Number: 576 0039 0258002; Email: piero.montorsi@ccfm.it
• Study Contact Backup: Name: Stefano Galli, MD; Phone Number: 533 0039 02 58002; Email: stefano.galli@ccfm.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20138
      • Recruiting
      • Centro Cardiologico Monzino, IRCCS
      • Contact: Piero Montorsi, MD; Phone Number: 576 0038 0258002
      • Contact: Stefano Galli, MD; Phone Number: 533 0038 0258002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stent Roadsaver® +Filterwire EZ™; The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection	Device: Filterwire EZ™; Device: Stent Roadsaver®
EXPERIMENTAL: Stent Roadsaver® + MO.MA Ultra; The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection	Device: Stent Roadsaver®; Device: MO.MA Ultra
EXPERIMENTAL: Carotid Wallstent +MO.MA Ultra; The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection	Device: MO.MA Ultra; Device: Carotid Wallstent
EXPERIMENTAL: Carotid Wallstent + Filterwire EZ™; The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection	Device: Filterwire EZ™; Device: Carotid Wallstent

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino

Publications and helpful links

General Publications

• Montorsi P, Caputi L, Galli S, Ravagnani PM, Teruzzi G, Annoni A, Calligaris G, Fabbiocchi F, Trabattoni D, de Martini S, Grancini L, Pontone G, Andreini D, Troiano S, Restelli D, Bartorelli AL. Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. JACC Cardiovasc Interv. 2020 Feb 24;13(4):403-414. doi: 10.1016/j.jcin.2019.09.007. Epub 2020 Jan 29.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ANTICIPATED): April 1, 2018
• Study Completion (ANTICIPATED): April 1, 2018

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (ESTIMATE): September 27, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 23, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: R323/15 - CCM334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO