Do vascular patches inserted after carotid endartectomy serve any purpose?
| ISRCTN | ISRCTN19452561 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19452561 |
| Protocol serial number | N0287023110 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrooke's (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) | Added July 2008: Clinical Outcome at 4 and 12 months |
| Key secondary outcome measure(s) | Added July 2008: Vessel Patency at 4 and 12 months |
| Completion date | 03/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 315 |
| 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
- United Kingdom
- England
Study participating centre
Box No 167
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
