Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
10/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Peter John Kirkpatrick

ORCID ID

Contact details

Box No 167
Department of Neurosurgery
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 01223 2451551 x3214
pjk21@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0287023110

Study information

Scientific title

Acronym

Study hypothesis

Use of vascular patches following carotid endarterectomy.

Ethics approval

Added 2008: study received ethical approval LREC No: 97/306

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular: Carotid endartectomy

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Added July 2008:
Clinical Outcome at 4 and 12 months

Secondary outcome measures

Added July 2008:
Vessel Patency at 4 and 12 months

Overall trial start date

20/01/1998

Overall trial end date

03/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Carotid endarterectomy patients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Added July 2008: 315 patients

Participant exclusion criteria

Added 2008:
Unable to give informed consent or refused consent to participate

Recruitment start date

20/01/1998

Recruitment end date

03/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 167
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17038946

Publication citations

  1. Results

    Al-Rawi PG, Turner CL, Waran V, Ng I, Kirkpatrick PJ, A randomized trial of synthetic patch versus direct primary closure in carotid endarterectomy., Neurosurgery, 2006, 59, 4, 822-8; discussion 828-9, doi: 10.1227/01.NEU.0000232640.11438.C0.

Additional files

Editorial Notes