Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy

Study Overview
=================
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

Official Title
-----------------
Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy. Long-term Results

Conditions
-----------------
Stroke, Carotid Artery Thrombosis, Carotid Artery Stenosis

Intervention / Treatment
-----------------
* Procedure: CEA


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEA + Polyester patch<br>225 Patients | Procedure: CEA<br>* Patients in both groups received an intra-operative angiography<br>* Other names: Carotid endarterectomy;|
| Experimental: CEA + Patch Polyurethane<br>225 Patients | Procedure: CEA<br>* Patients in both groups received an intra-operative angiography<br>* Other names: Carotid endarterectomy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid artery restenosis | Restenosis of carotid endarterectomy > 70% in diameter occurring 5 to 10 years after surgery diagnosed by color duplex ultrasound | 5 to 10 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any death occurring during follow-up | All death even those not related to carotid surgery | 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 | 0 days to 10 years |