NCT00597974|Completed
Neurological Outcome With Carotid Artery Stenting
CAS
Evaluation of Neurological Outcome in Patients Undergoing Cerebral Angiography and Revascularization Using Angioplasty and Stent-Supported Angioplasty
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CAS
Evaluation of Neurological Outcome in Patients Undergoing Cerebral Angiography and Revascularization Using Angioplasty and Stent-Supported Angioplasty
Sponsor study identifier
observational
108
1 country
1
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)The purpose of this study is to determine how well patients undergoing carotid artery angioplasty and/or stent-supported angioplasty for the treatment of carotid artery stenosis will perform on a battery of tests to assess brain function before and after the procedure. This study will serve as a pilot project: (a) to determine incidence of neurologic/neuropsychometric change in patients undergoing carotid artery angioplasty and/or stent-supported angioplasty, and (b) to ascertain the time it takes for these changes to resolve.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
January 9, 2008
Actual (reported)January 18, 2008
Actual (reported)April 2014
Actual (reported)April 2014
Actual (reported)Neuropsychometric Changes
Battery of neuropsychometric tests will assess performance pre-operatively and compare the post-operative performance at 1 day.
Baseline to 1 day post-op
Neuropsychometric Changes
Baseline to 1 month
Patients undergoing carotid artery angioplasty and/or stent-supported angioplasty for the treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations
Patients undergoing coronary angiography for the treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations
(non-experimental) Carotid artery angioplasty and/or stent-supported angioplasty
(non-experimental) Precise™ Nitinol Self-Expanding Stent (Cordis Endovascular, Johnson \& Johnson), S.M.A.R.T.® Control™ Stent (Cordis Endovascular, Johnson \& Johnson), Wallstent® (Boston Scientific Medi-Tech)
Columbia University/NY Presbyterian Hospital
Columbia University, Department of Anesthesiology
New York, New York, 10032, United States
Roubin GS, New G, Iyer SS, Vitek JJ, Al-Mubarak N, Liu MW, Yadav J, Gomez C, Kuntz RE. Immediate and late clinical outcomes of carotid artery stenting in patients with symptomatic and asymptomatic carotid artery stenosis: a 5-year prospective analysis. Circulation. 2001 Jan 30;103(4):532-7. doi: 10.1161/01.cir.103.4.532.
Theron JG, Payelle GG, Coskun O, Huet HF, Guimaraens L. Carotid artery stenosis: treatment with protected balloon angioplasty and stent placement. Radiology. 1996 Dec;201(3):627-36. doi: 10.1148/radiology.201.3.8939208.
plasma serum DNA (obtained via buccal samples using a buccal cell collection swab)
Eric J Heyer, M.D., Ph.D.
Columbia University
108 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2008
First Posted
January 18, 2008
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Clinical examinations consisting of a neurological and neuropsychological evaluation
(non-experimental) Coronary angiography
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Diethrich EB, Ndiaye M, Reid DB. Stenting in the carotid artery: initial experience in 110 patients. J Endovasc Surg. 1996 Feb;3(1):42-62. doi: 10.1583/1074-6218(1996)0032.0.CO;2.
Wholey MH, Wholey MH, Jarmolowski CR, Eles G, Levy D, Buecthel J. Endovascular stents for carotid artery occlusive disease. J Endovasc Surg. 1997 Nov;4(4):326-38. doi: 10.1177/152660289700400402.
Henry M, Amor M, Klonaris C, Henry I, Masson I, Chati Z, Leborgne E, Hugel M. Angioplasty and stenting of the extracranial carotid arteries. Tex Heart Inst J. 2000;27(2):150-8.
Heyer EJ, Sharma R, Rampersad A, Winfree CJ, Mack WJ, Solomon RA, Todd GJ, McCormick PC, McMurtry JG, Quest DO, Stern Y, Lazar RM, Connolly ES. A controlled prospective study of neuropsychological dysfunction following carotid endarterectomy. Arch Neurol. 2002 Feb;59(2):217-22. doi: 10.1001/archneur.59.2.217.
Meyers, Philip M, Lavine, Sean D, Higashida, Randall T, Endovascular Revascularization of Carotid Artery Disease in Controversies in neurological Surgery: Neurovascular Diseases, In Press 2003.
Primary Completion
April 2014
Actual (reported)Study Completion
April 2014
Actual (reported)Last Updated
June 4, 2015
Record last verified: 2015-06
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Source: ClinicalTrials.gov.
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