PROximal Protection VErsus NON-Protection in Carotid Artery Stenting

Phase 3

• Conditions: Carotid Artery Stenosis
• Interventions: Procedure: Carotid Artery Stenting without Protection; Procedure: Carotid Artery Stenting with Proximal Protection

• Registration Number: NCT01331473
• Lead Sponsor: Universität des Saarlandes

Brief 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.

Study Timeline

• Status Verified: 2011-03
• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-08
• Study Start: 2011-05
• Last Update Submitted: 2011-12-02
• Last Update Posted: 2011-12-05
• Primary Completion: 2014-05
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Male and female ≥ 18 years old;
• Suitable/Eligible for carotid artery revascularization;
• Significant artery stenosis in symptomatic patients defined as ≥ 50% of the artery diameter (%DS) or asymptomatic ≥ 80 %DS by angiography. Symptomatic is defined as a carotid artery stenosis associated with ipsilateral transient ischemic attack (TIA), amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment.
• Adequate clinical conditions to perform DW-MRI.
• Ability of the individual to understand the character and the consequences of clinical trial.
• Signed and dated informed consent provided before the beginning of any intervention.
• Negative pregnancy test (serum or urine) and contraception use for any woman of childbearing age. Systematic contraceptives (oral, implant, injection) and dia-phragm or condoms with spermicidal are considered reliable. Women who have undergone bilateral oophorectomy or/and hysterectomy or women status post-menopausal for at least two years are eligible for this trial.

Exclusion Criteria

• Intracranial hemorrhage, hemorrhagic stroke, or stroke with mass effect demonstrated on CT scan or MRI within 30 days of the index procedure.
• Persisting ischemic stroke (defined as either a score > 15 on the NIH stroke scale, a Rankin score > 3 or a Barthel score < 60 measured within one week prior to study entry).
• Intracranial mass lesion (i.e., abscess, tumor, or other infection).
• peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding the use of catheter-based techniques required for successful results.
• Lactation.
• Arterio-venous malformation in the territory of the target carotid artery.
• Any disease or medication that affects local hemostasis,
• Participation in other clinical trials during the present clinical trial or within the last month.
• Medical or psychological condition that would not permit completion of the trial or signing of informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carotid Artery Stenting without Protection	Carotid Artery Stenting without Protection	Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and without embolic protection device
Carotid Artery Stenting with Proximal Protection	Carotid Artery Stenting with Proximal Protection	Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and with a proximal embolic protection device provided by the GORE Neuro Protection System

Primary Outcome Measures

Name	Time	Method
The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging	Day 1-3

Secondary Outcome Measures

Name	Time	Method
Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment	Day 30
Technical Success of the procedure	Day 0	Subjects (both groups) who due to technical reaseons are unable to performe carotid artery stenting will be considered as technical failures.; Subjects who are unable to tolerate flow reversal (in group 2) and have their procedures completed without embolic protection or other methods will be also considered as technical failures.
Access site vascular complications, defined as need for surgical repair or blood transfusion	Day 0-7

Trial Locations

Locations (1)

Department of Diagnostic and Interventional Neuroradiology; 🇩🇪 Homburg, Saarland, Germany