Total Cerebral Protection With Embolic Protection Devices Thoracic Aortic Stenting

Study Overview
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Brief Summary
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Stroke and silent cerebral infarction are a real risk with thoracic enodvascular aortic repair (TEVAR). The investigator propose to prospectively observational study with enrolment of all patients undergoing TEVAR for thoracic and thoracoabdominal conditions including aneurysmal degeneration, Type B dissection and acute aortic syndromes over a 24 month period, equating to a minimum of 20-30 patients per year. Patients undergoing juxtra-renal and infra-renal aortic stenting will form a control group.

Detailed Description
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TEVAR involves the insertion of a stent into the thoracic aorta to re-line it and prevent life-threatening haemorrhage from rupture, and ultimately death. The stent is inserted through a small cut in the femoral artery in the groin that is able to track to the desired location in the thoracic aorta over wires. The thoracic aorta and the branches it provides to supply the brain are diseased with atherosclerotic plaques and thrombus. The manipulation of wires and stents over these diseased locations can lead to small fragments breaking off and travelling to the brain to block the blood supply to areas of the brain (cerebral embolisation). Cerebral embolic protection devices (CEPDs) consist of filters that can be placed into the branches of the thoracic aorta that supply the brain(supra-aortic branches) before TEVAR and can capture and remove solid debris, preventing it from reaching the brain.

Official Title
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Total Cerebral Protection With Embolic Protection Devices in Thoracic Aortic Stenting

Conditions
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Stroke, Silent Cerebral Infarct

Intervention / Treatment
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* Device: Sentinel and Spider


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients requiring TEVAR as decided upon by a multidisciplinary meeting Exclusion Criteria: Contraindication to MRI scanning Unable to give consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Sentinel and Spider|Dual filter and single filter|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of brain injury assessed by Magnetic resonance imaging (MRI) test | Magnetic resonance imaging (MRI) of the brain is a safe and painless test that uses a magnetic field and radio waves to produce detailed images of the brain. | Pre-operative and post-operative up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of embolic event | Transcranial doppler monitoring of embolic events | Intra-operative | 
| Changes in neurocognition function | Neurocognitive tests to assess the changes in neurocognition function | Pre-operative and post-operative up until 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, cerebral embolic protection device