- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02341196
Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy
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
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Experimental: CEA + Patch Polyurethane
225 Patients
|
Patients in both groups received an intra-operative angiography
Other Names:
|
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
Sponsor
Collaborators
Investigators
- Study Chair: Giulio Illuminati, MD, PhD, University of Roma La Sapienza
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arterial Occlusive Diseases
- Embolism and Thrombosis
- Carotid Artery Diseases
- Intracranial Embolism and Thrombosis
- Thromboembolism
- Carotid Stenosis
- Thrombosis
- Carotid Artery Thrombosis
Other Study ID Numbers
- JBR01
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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