Trials / Completed
CompletedNCT02341196
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 450 (actual)
- Sponsor
- University of Poitiers · Academic / Other
- Sex
- All
- Age
- 25 Years – 90 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | CEA | Patients in both groups received an intra-operative angiography |
Timeline
- Start date
- 1995-01-01
- Primary completion
- 2004-01-01
- Completion
- 2014-12-01
- First posted
- 2015-01-19
- Last updated
- 2015-01-19
Source: ClinicalTrials.gov record NCT02341196. Inclusion in this directory is not an endorsement.