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

Completed

Phase N/A Results N/A

Trial 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.
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

Conditions

Interventions

  • CEA Procedure
    Intervention Desc: Patients in both groups received an intra-operative angiography
    ARM 1: Kind: Experimental
    Label: CEA + Polyester patch
    Description: 225 Patients
    ARM 2: Kind: Experimental
    Label: CEA + Patch Polyurethane
    Description: 225 Patients

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary carotid artery restenosis 5 to 10 years after surgery No
Secondary Any death occurring during follow-up Time 0 (operation) to 10 years after surgery No
Secondary Any ipsilateral stroke 0 days to 10 years No

Sponsors