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NCT Number: NCT02341196

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

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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Key information

Conditions

Carotid Artery Thrombosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Artery Stenosis Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Intracranial Embolism and Thrombosis Nervous System Diseases Stroke Thromboembolism Vascular Diseases

Age range

25 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CEA

Procedure

Patients in both groups received an intra-operative angiography

Other names: Carotid endarterectomy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Poitiers

Other

Collaborators

  • University of Roma La Sapienza

Registry information

Official study title

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

Important dates

Study start
1995
Primary completion
2004
Study completion
2014
First posted
Jan 19, 2015
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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