Randomized Clinical Trial of Polyester vs. Polyurethane Patch for Carotid Endarterectomy. Long-term Results
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Poitiers
- Enrollment
- 450
- Primary Endpoint
- carotid artery restenosis
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CEA + Polyester patch
225 Patients
Intervention: CEA (Procedure)
CEA + Patch Polyurethane
225 Patients
Intervention: CEA (Procedure)
Outcomes
Primary Outcomes
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
- Any ipsilateral stroke(0 days to 10 years)
- Any death occurring during follow-up(Time 0 (operation) to 10 years after surgery)