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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-01-31

Study Completion Date

2014-12-31

Brief Summary

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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)

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Detailed Description

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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

Conditions

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Carotid Artery Thrombosis Carotid Artery Stenosis Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CEA + Polyester patch

225 Patients

Group Type EXPERIMENTAL

CEA

Intervention Type PROCEDURE

Patients in both groups received an intra-operative angiography

CEA + Patch Polyurethane

225 Patients

Group Type EXPERIMENTAL

CEA

Intervention Type PROCEDURE

Patients in both groups received an intra-operative angiography

Interventions

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CEA

Patients in both groups received an intra-operative angiography

Intervention Type PROCEDURE

Other Intervention Names

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Carotid endarterectomy

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No