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.

Carotid Stenosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02915328
• Other study ID #: R323/15 - CCM334
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2016
• Last updated: September 23, 2016
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: September 2016
• Source: Centro Cardiologico Monzino
• Contact: Piero Montorsi, MD
• Phone: 0039 0258002
• Email: piero.montorsi[@]ccfm.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Device:
• Filterwire EZ™

• MO.MA Ultra

• Stent Roadsaver®

• Carotid Wallstent

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino, IRCCS	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Clinical success	all strokes, major and minor strokes, myocardial infarction	day 2 or day 3 and day 30 complication	Yes
Secondary	6 month clinical follow up	all strokes, major and minor strokes, myocardial infarction	6 month	Yes
Secondary	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	Yes