PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01331473|
Recruitment Status : Unknown
Verified March 2011 by Saarland University.
Recruitment status was: Recruiting
First Posted : April 8, 2011
Last Update Posted : December 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Stenosis||Procedure: Carotid Artery Stenting with Proximal Protection Procedure: Carotid Artery Stenting without Protection||Phase 3|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON Study) A Randomized Prospective MRI-based Trial.|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||June 2014|
Active Comparator: Carotid Artery Stenting without Protection
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
Carotid artery angioplasty and stenting without cerebral embolic protection
Active Comparator: 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
Procedure: Carotid Artery Stenting with Proximal Protection
Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System
- The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging [ Time Frame: Day 1-3 ]
- Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment [ Time Frame: Day 30 ]
- Technical Success of the procedure [ Time Frame: 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 [ Time Frame: Day 0-7 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331473
|Contact: Panagiotis Papanagiotou, MD||+49684116 ext email@example.com|
|Contact: Christian Roth, MD||+49684116 ext firstname.lastname@example.org|
|Department of Diagnostic and Interventional Neuroradiology||Recruiting|
|Homburg, Saarland, Germany, 66424|
|Contact: Panagiotis Papanagiotou, MD 49684116 ext 24302 email@example.com|
|Contact: Christian Roth, MD 49684116 ext 24302 firstname.lastname@example.org|
|Principal Investigator: Wolfgang Reith, MD|
|Sub-Investigator: Panagiotis Papanagiotou, MD|
|Sub-Investigator: Christian Roth, MD|
|Principal Investigator:||Wolfgang Reith, MD||Saarland University Hospital|