Carotid Artery Thrombosis, Carotid Artery Stenosis, Stroke
Conditions
Brief summary
This study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years. This study was run at the University of Roma, La Sapienza and at the University of Poitiers, randomisation was done in both enters after approval by the Ethical committee of the University of Roma (Record uploaded)
Detailed description
This study examines the risk of thrombogenicity of the carotid patches in polyurethane compared to carotid patches in polyester including death, any stroke, carotid thrombosis at 30 days and long-term results including stroke and recurrent carotid stenosis at 10 years. 598 patients were considered for randomisation between January 1995 and January 2004. The following patients were excluded for randomisation (Redo carotid surgery: N=34, radiation induced carotid stenosis:N=45, indication for carotid bypass: N=65, Refusal of randomisation: N=4). In total, 450 patients were randomized in two groups, 225 received a polyester patch and 225 received a polyurethane patch. All patients were operated under general anaesthesia and all received an intraoperative angiography. A shunt was selectively used in patients with a recent stroke (\<15 days) or with a contralateral carotid occlusion
Interventions
PROCEDURECEA
Patients in both groups received an intra-operative angiography
Sponsors
University of Roma La Sapienza
University of Poitiers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Carotid stenosis \> 60% NASCET criteria
Exclusion criteria
* Redo carotid surgery * Radiation induced carotid stenosis * Extensive carotid lesion \> 5 cm in length with involvement of the common carotid artery best treated by a carotid bypass
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| carotid artery restenosis | 5 to 10 years after surgery | Restenosis of carotid endarterectomy \> 70% in diameter occurring 5 to 10 years after surgery diagnosed by color duplex ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any death occurring during follow-up | Time 0 (operation) to 10 years after surgery | All death even those not related to carotid surgery |
| Any ipsilateral stroke | 0 days to 10 years | Any paralysis occurring in relation with the operated carotid artery and lasting more than 24 hours |
Outcome results
None listed