NCT01331473

PROximal Protection VErsus NON-Protection in Carotid Artery Stenting

PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON Study) A Randomized Prospective MRI-based Trial.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Universität des Saarlandes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the incidence of new ischemic brain injury detected with magnetic resonance imaging (MRI) after carotid artery stenting in patients treated with and without proximal cerebral protection (Gore Flow Reversal System).

Detailed description

Primary Objective: The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting between patients treated with proximal cerebral protection (Gore Flow Reversal System) and without cerebral protection. Secondary Objective: Impact of MRI-morphology of atherosclerotic plaque to the rate of new hyperintense diffusion weighted imaging (DWI) lesion on the post-treatment scan and to the rate of ipsilateral stroke or death.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
PROCEDURE	Carotid Artery Stenting with Proximal Protection	Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System
PROCEDURE	Carotid Artery Stenting without Protection	Carotid artery angioplasty and stenting without cerebral embolic protection

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2011-04-08
• Last updated: 2011-12-05

Locations

1 site across 1 country: Germany