Back to resultsRandomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy
Primary Purpose
Carotid Artery Thrombosis, Carotid Artery Stenosis, Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CEA
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Artery Thrombosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CEA + Polyester patch
CEA + Patch Polyurethane
Arm Description
225 Patients
225 Patients
Outcomes
Primary Outcome Measures
carotid artery restenosis
Restenosis of carotid endarterectomy > 70% in diameter occurring 5 to 10 years after surgery diagnosed by color duplex ultrasound
Secondary Outcome Measures
Any death occurring during follow-up
All death even those not related to carotid surgery
Any ipsilateral stroke
Any paralysis occurring in relation with the operated carotid artery and lasting more than 24 hours
Full Information
NCT ID
NCT02341196
First Posted
December 21, 2014
Last Updated
January 13, 2015
Sponsor
University of Poitiers
Collaborators
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT02341196
Brief Title
Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy
Official Title
Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy. Long-term Results
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 1995 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Poitiers
Collaborators
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Thrombosis, Carotid Artery Stenosis, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CEA + Polyester patch
Arm Type
Experimental
Arm Description
225 Patients
Arm Title
CEA + Patch Polyurethane
Arm Type
Experimental
Arm Description
225 Patients
Intervention Type
Procedure
Intervention Name(s)
CEA
Other Intervention Name(s)
Carotid endarterectomy
Intervention Description
Patients in both groups received an intra-operative angiography
Primary Outcome Measure Information:
Title
carotid artery restenosis
Description
Restenosis of carotid endarterectomy > 70% in diameter occurring 5 to 10 years after surgery diagnosed by color duplex ultrasound
Time Frame
5 to 10 years after surgery
Secondary Outcome Measure Information:
Title
Any death occurring during follow-up
Description
All death even those not related to carotid surgery
Time Frame
Time 0 (operation) to 10 years after surgery
Title
Any ipsilateral stroke
Description
Any paralysis occurring in relation with the operated carotid artery and lasting more than 24 hours
Time Frame
0 days to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giulio Illuminati, MD, PhD
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy
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