NCT00597974

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

10.6 years

First QC Date

January 9, 2008

Last Update Submit

June 2, 2015

Conditions

Carotid Artery DiseaseCarotid Artery StenosisStrokeTransient Ischemic Attack

Keywords

carotid artery stenosisNeuropsychological testsStrokeTransient ischemiaStenting

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Neuropsychometric Changes

    Baseline to 1 month

Study Arms (2)

Patients having angioplasty (case)

Patients undergoing carotid artery angioplasty and/or stent-supported angioplasty for the treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations

Procedure: AngioplastyDevice: StentOther: Neurological and neuropsychological evaluationsProcedure: Angiography

Patients having angiography (control)

Patients undergoing coronary angiography for the treatment of carotid artery stenosis will receive neurological and neuropsychological evaluations

Procedure: AngioplastyDevice: StentOther: Neurological and neuropsychological evaluationsProcedure: Angiography

Interventions

AngioplastyPROCEDURE

(non-experimental) Carotid artery angioplasty and/or stent-supported angioplasty

Patients having angiography (control)Patients having angioplasty (case)
StentDEVICE

(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)

Patients having angiography (control)Patients having angioplasty (case)
Neurological and neuropsychological evaluationsOTHER

Clinical examinations consisting of a neurological and neuropsychological evaluation

Patients having angiography (control)Patients having angioplasty (case)
AngiographyPROCEDURE

(non-experimental) Coronary angiography

Patients having angiography (control)Patients having angioplasty (case)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Columbia University/NY Presbyterian Hospital

You may qualify if:

  • ability to speak English or Spanish
  • scheduled to undergo carotid artery angioplasty and/or stent-supported angioplasty or coronary angiography

You may not qualify if:

  • history of permanent neurological impairment
  • Axis I psychiatric diagnosis or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University, Department of Anesthesiology

New York, New York, 10032, United States

Location

Related Publications (7)

  • 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.

    PMID: 11157718BACKGROUND

  • 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.

    PMID: 8939208BACKGROUND

  • 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.

    PMID: 8798126BACKGROUND

  • 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.

    PMID: 9418194BACKGROUND

  • 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.

    PMID: 10928503BACKGROUND

  • 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.

    PMID: 11843692BACKGROUND

  • 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.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma serum DNA (obtained via buccal samples using a buccal cell collection swab)

MeSH Terms

Conditions

Carotid Artery DiseasesCarotid StenosisStrokeIschemic Attack, Transient

Interventions

AngioplastyStentsCerebral Angiography

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArterial Occlusive DiseasesBrain Ischemia

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative TechniquesProstheses and ImplantsEquipment and SuppliesNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques, Neurological

Study Officials

  • Eric J Heyer, M.D., Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Anesthesiology

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

September 1, 2003

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

US(1)