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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN19452561 |
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Date of registration:
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12/09/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Do vascular patches inserted after carotid endartectomy serve any purpose?
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Scientific title:
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Date of first enrolment:
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20/01/1998 |
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Target sample size:
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315 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN19452561 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Peter John
Kirkpatrick |
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Address:
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Box No 167
Department of Neurosurgery
Addenbrooke's Hospital
Hills Road
CB2 2QQ
Cambridge
United Kingdom |
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Telephone:
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+44 01223 2451551 x3214 |
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Email:
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pjk21@medschl.cam.ac.uk |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: Carotid endarterectomy patients
Exclusion criteria: Added 2008:
Unable to give informed consent or refused consent to participate
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Cardiovascular: Carotid endartectomy
Circulatory System
Carotid endartectomy
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Intervention(s)
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The insertion of a vascular patch following carotid endartectomy has been sporadically used after many years, but is of no proven worth. Advocates of patch insertion suggest that the vessel patency rate is higher, the chances of thrombosis lower and the chances of re-stenosis also lower. There is no scientific basis to support this notion. In this study we wish to randomise patients undergoing carotid endartectomy into those having a patch versus those in whom the vessel is repaired conventionally.
We will measure the blood flow velocity in the middle cerebral artery before and after removal of the clamps as is conventional and we will compare the vessel patency rate at 3 and 12 months, in the two groups.
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Primary Outcome(s)
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Added July 2008:
Clinical Outcome at 4 and 12 months
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Secondary Outcome(s)
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Added July 2008:
Vessel Patency at 4 and 12 months
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Secondary ID(s)
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N0287023110
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Source(s) of Monetary Support
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Cambridge Consortium - Addenbrooke's (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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