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Total Cerebral Protection With Embolic Protection Devices Thoracic Aortic Stenting

Imperial College London logo

Imperial College London

Status

Suspended

Conditions

Stroke
Silent Cerebral Infarct

Treatments

Device: Sentinel and Spider

Study type

Observational

Funder types

Other

Identifiers

NCT04062539
INTERCEPT:CEPD

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients requiring TEVAR as decided upon by a multidisciplinary meeting

Exclusion criteria

  • Contraindication to MRI scanning
  • Unable to give consent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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