PROximal Protection VErsus NON-Protection in Carotid Artery Stenting
NCT ID: NCT01331473
Last Updated: 2011-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
220 participants
INTERVENTIONAL
2011-05-31
2014-06-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 without Protection
Carotid artery angioplasty and stenting without cerebral embolic 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
Carotid Artery Stenting with Proximal Protection
Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System
Interventions
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Carotid Artery Stenting with Proximal Protection
Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System
Carotid Artery Stenting without Protection
Carotid artery angioplasty and stenting without cerebral embolic protection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Universität des Saarlandes
OTHER
Responsible Party
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Department of Diagnostic and Interventional Neuroradiology
Principal Investigators
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Wolfgang Reith, MD
Role: PRINCIPAL_INVESTIGATOR
Saarland University Hospital
Locations
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Department of Diagnostic and Interventional Neuroradiology
Homburg, Saarland, Germany
Countries
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Central Contacts
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Facility Contacts
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Panagiotis Papanagiotou, MD
Role: primary
Christian Roth, MD
Role: backup
References
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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.
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.
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.
Other Identifiers
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PROVENON01
Identifier Type: -
Identifier Source: org_study_id