An interventional study of CEA in Carotid Artery Thrombosis, Carotid Artery Stenosis and Stroke, sponsored by University of Poitiers. Completed. Open to participants aged 25 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-01-19.
Sponsored by University of Poitiers · Not applicable, Interventional, and Treatment
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)
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
339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.
This study's enrollment of 450 is above the median of 106 across 182 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →University of Poitiers is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
225 Patients
Procedure: CEA
225 Patients
Procedure: CEA
Patients in both groups received an intra-operative angiography
Also known as: Carotid endarterectomy
carotid artery restenosis
Restenosis of carotid endarterectomy \> 70% in diameter occurring 5 to 10 years after surgery diagnosed by color duplex ultrasound
Time frame: 5 to 10 years after surgery
Any death occurring during follow-up
All death even those not related to carotid surgery
Time frame: Time 0 (operation) to 10 years after surgery
Any ipsilateral stroke
Any paralysis occurring in relation with the operated carotid artery and lasting more than 24 hours
Time frame: 0 days to 10 years
No study locations are listed for this record.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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University of Poitiers