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Waiting for funding
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| Name | Class |
|---|---|
| St Mary's Hospital, London | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel and Spider | Device | Dual filter and single filter |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Secondary care; elective patients from an outpatient clinical bases and emergency patients presenting through Accident and Emergency
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| Name | Affiliation | Role |
|---|---|---|
| Richard Gibbs | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Mary's Hospital | London | W21NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29431856 | Background | Perera AH, Rudarakanchana N, Monzon L, Bicknell CD, Modarai B, Kirmi O, Athanasiou T, Hamady M, Gibbs RG. Cerebral embolization, silent cerebral infarction and neurocognitive decline after thoracic endovascular aortic repair. Br J Surg. 2018 Mar;105(4):366-378. doi: 10.1002/bjs.10718. Epub 2018 Feb 12. | |
| 29804744 | Background |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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All captured material from the filters will be analysed and this can include atherosclerotic particles and thrombus.
| Pre-operative and post-operative up until 6 months |
| Grover G, Perera AH, Hamady M, Rudarakanchana N, Barras CD, Singh A, Davies AH, Gibbs R. Cerebral embolic protection in thoracic endovascular aortic repair. J Vasc Surg. 2018 Dec;68(6):1656-1666. doi: 10.1016/j.jvs.2017.11.098. Epub 2018 May 24. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |