PROximal Protection VErsus NON-Protection in Carotid Artery Stenting

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carotid Artery Stenosis

Intervention / Treatment
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* Procedure: Carotid Artery Stenting with Proximal Protection
* Procedure: Carotid Artery Stenting without Protection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carotid Artery Stenting without Protection<br>Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and without embolic protection device | Procedure: Carotid Artery Stenting without Protection<br>* Carotid artery angioplasty and stenting without cerebral embolic protection<br>|
| Active Comparator: Carotid Artery Stenting with Proximal Protection<br>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 | Procedure: Carotid Artery Stenting with Proximal Protection<br>* Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Day 0 | 
| Access site vascular complications, defined as need for surgical repair or blood transfusion |  | Day 0-7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid Artery, Stenting, CAS, proximal protection