NCT02915328

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

September 20, 2016

Last Update Submit

September 23, 2016

Conditions

Carotid Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Clinical success

    day 2 or day 3 and day 30 complication

  • 6 month clinical follow up

    6 month

  • Doppler ultrasound assesment

    day 2 or day 3, 1 month and 6 month

Study Arms (4)

Stent Roadsaver® +Filterwire EZ™

EXPERIMENTAL

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

Device: Filterwire EZ™Device: Stent Roadsaver®

Stent Roadsaver® + MO.MA Ultra

EXPERIMENTAL

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

Device: MO.MA UltraDevice: Stent Roadsaver®

Carotid Wallstent +MO.MA Ultra

EXPERIMENTAL

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

Device: MO.MA UltraDevice: Carotid Wallstent

Carotid Wallstent + Filterwire EZ™

EXPERIMENTAL

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

Device: Filterwire EZ™Device: Carotid Wallstent

Interventions

Filterwire EZ™DEVICE
Carotid Wallstent + Filterwire EZ™Stent Roadsaver® +Filterwire EZ™
MO.MA UltraDEVICE
Carotid Wallstent +MO.MA UltraStent Roadsaver® + MO.MA Ultra
Stent Roadsaver®DEVICE
Stent Roadsaver® + MO.MA UltraStent Roadsaver® +Filterwire EZ™
Carotid WallstentDEVICE
Carotid Wallstent + Filterwire EZ™Carotid Wallstent +MO.MA Ultra

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • severe cerebral vasculopathy with cognitive impairment
  • contraindication to double antiplatelet treatment
  • controlateral carotid occlusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino, IRCCS

Milan, MI, 20138, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32007460DERIVED

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Piero Montorsi, MD

    Centro Cardiologico Monzino, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Piero Montorsi, MD

CONTACT

0039 0258002piero.montorsi@ccfm.it

Stefano Galli, MD

CONTACT

0039 02 58002stefano.galli@ccfm.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 27, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

September 27, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)