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

Not Applicable

Completed

• Conditions: Carotid Artery Thrombosis; Stroke; Carotid Artery Stenosis
• Interventions: Procedure: CEA

• Registration Number: NCT02341196
• Lead Sponsor: University of Poitiers

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

Study Timeline

• Study Start: 1995-01
• Primary Completion: 2004-01
• Study Completion: 2014-12
• Study First Submitted: 2014-12-21
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-13
• Last Update Submitted: 2015-01-13
• Study First Posted: 2015-01-19
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Carotid stenosis > 60% NASCET criteria

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CEA + Polyester patch	CEA	225 Patients
CEA + Patch Polyurethane	CEA	225 Patients

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Any ipsilateral stroke	0 days to 10 years	Any paralysis occurring in relation with the operated carotid artery and lasting more than 24 hours
Any death occurring during follow-up	Time 0 (operation) to 10 years after surgery	All death even those not related to carotid surgery