Clinical trial NCT01331473: PROximal Protection VErsus NON-Protection in Carotid Artery Stenting
Official title: PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON Study) A Randomized Prospective MRI-based Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carotid Artery Stenosis
Keywords: Carotid Artery
Stenting
CAS
proximal protection
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2011-04-08
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging
timeFrame: Day 1-3
Secondary outcomes:
measure: Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment
timeFrame: Day 30
measure: Technical Success of the procedure
timeFrame: Day 0
measure: Access site vascular complications, defined as need for surgical repair or blood transfusion
timeFrame: Day 0-7
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Department of Diagnostic and Interventional Neuroradiology
state: Saarland
Study officials:
affiliation: Saarland University Hospital
name: Wolfgang Reith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grunwald IQ, Papanagiotou P, Roth C, Fassbender K, Karp K, Krick C, Schieber H, Muller M, Haass A, Reith W. Lesion load in unprotected carotid artery stenting. Neuroradiology. 2009 May;51(5):313-7. doi: 10.1007/s00234-008-0491-6. Epub 2009 Feb 6.
citation: Grunwald IQ, Papanagiotou P, Struffert T, Politi M, Krick C, Romaike BF, Ahlhelm F, Reith W. Reversal of flow during carotid artery stenting: use of the Parodi antiembolism system. Neuroradiology. 2007 Mar;49(3):237-41. doi: 10.1007/s00234-006-0178-9. Epub 2007 Jan 5.
citation: Kastrup A, Nagele T, Groschel K, Schmidt F, Vogler E, Schulz J, Ernemann U. Incidence of new brain lesions after carotid stenting with and without cerebral protection. Stroke. 2006 Sep;37(9):2312-6. doi: 10.1161/01.STR.0000236492.86303.85. Epub 2006 Aug 3.