Do vascular patches inserted after carotid endartectomy serve any purpose?
| ISRCTN | ISRCTN19452561 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19452561 |
| Secondary identifying numbers | N0287023110 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 10/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Peter John Kirkpatrick
Scientific
Scientific
Box No 167
Department of Neurosurgery
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 01223 2451551 x3214 |
|---|---|
| pjk21@medschl.cam.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Use of vascular patches following carotid endarterectomy. |
| Ethics approval(s) | Added 2008: study received ethical approval LREC No: 97/306 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Added July 2008: Clinical Outcome at 4 and 12 months |
| Secondary outcome measures | Added July 2008: Vessel Patency at 4 and 12 months |
| Overall study start date | 20/01/1998 |
| Completion date | 03/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Added July 2008: 315 patients |
| Key inclusion criteria | Carotid endarterectomy patients |
| Key exclusion criteria | Added 2008: Unable to give informed consent or refused consent to participate |
| Date of first enrolment | 20/01/1998 |
| Date of final enrolment | 03/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box No 167
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Cambridge Consortium - Addenbrooke's (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2006 | Yes | No |
