NCT00390481

Brief Summary

To determine the relationship between cognitive functioning and blood flow in the brain among patients randomized to either extracranial-intracranial (EC-IC) bypass or medical therapy alone in the Carotid Occlusion Surgery Study (COSS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

7.6 years

First QC Date

October 17, 2006

Last Update Submit

July 29, 2013

Conditions

Carotid Artery Diseases

Keywords

Carotid OcclusionCognition

Outcome Measures

Primary Outcomes (1)

  • Cognitive Functioning on Neuropsychological assessment measures

    2 years

Secondary Outcomes (1)

  • Quality of Life and Disability

    2 years

Study Arms (2)

Intervention

OTHER

EC-IC Bypass

Procedure: EC-IC Bypass in the COSS study

Control

NO INTERVENTION

Best Medical Therapy

Interventions

EC-IC Bypass in the COSS studyPROCEDURE

EC-IC Bypass surgery involves taking an artery from the scalp outside the skull, making a small hole in the skull, and then connecting the scalp artery to a brain artery inside the skull. In this way, the blockage of the carotid artery in the neck is bypassed and more blood can flow to the brain.

Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrollment into Carotid Occlusion Surgery Study

You may not qualify if:

  • Prior diagnosis of dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Links

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Randolph S Marshall, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Joanne R Festa, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor at Affil Hosp/Inst

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 19, 2006

Study Start

November 1, 2004

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 30, 2013

Record last verified: 2013-07

Locations

US(1)