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

NCT02341196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2015-01-19

No results posted yet for this study

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)

Conditions

  • Carotid Artery Thrombosis
  • Carotid Artery Stenosis
  • Stroke

Interventions

PROCEDURE

CEA

Patients in both groups received an intra-operative angiography

Sponsors & Collaborators

  • University of Roma La Sapienza

    collaborator OTHER

  • University of Poitiers

    lead OTHER

Principal Investigators

  • Giulio Illuminati, MD, PhD · University of Roma La Sapienza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-01-31
Primary Completion
2004-01-31
Completion
2014-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02341196 on ClinicalTrials.gov