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

January 13, 2015 updated by: University of Poitiers

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

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)

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CEA + Polyester patch
225 Patients
Patients in both groups received an intra-operative angiography
Other Names:
  • Carotid endarterectomy
Experimental: CEA + Patch Polyurethane
225 Patients
Patients in both groups received an intra-operative angiography
Other Names:
  • Carotid endarterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
carotid artery restenosis
Time Frame: 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
5 to 10 years after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Giulio Illuminati, MD, PhD, University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1995

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 21, 2014

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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