PROximal Protection VErsus NON-Protection in Carotid Artery Stenting
PROVENON
1 other identifier
interventional
220
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 8, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedDecember 5, 2011
March 1, 2011
3 years
March 30, 2011
December 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging
Day 1-3
Secondary Outcomes (3)
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
Access site vascular complications, defined as need for surgical repair or blood transfusion
Day 0-7
Study Arms (2)
Carotid Artery Stenting without Protection
ACTIVE COMPARATORSubjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and without embolic protection device
Carotid Artery Stenting with Proximal Protection
ACTIVE COMPARATORSubjects 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
Interventions
Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System
Carotid artery angioplasty and stenting without cerebral embolic protection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Diagnostic and Interventional Neuroradiology
Homburg, Saarland, 66424, Germany
Related Publications (3)
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.
PMID: 19198823BACKGROUNDGrunwald 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.
PMID: 17205314BACKGROUNDKastrup 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.
PMID: 16888277BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Reith, MD
Saarland University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 8, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2014
Study Completion
June 1, 2014
Last Updated
December 5, 2011
Record last verified: 2011-03