Total Cerebral Protection With Embolic Protection Devices Thoracic Aortic Stenting

Suspended

• Conditions: Silent Cerebral Infarct; Stroke

• Registration Number: NCT04062539
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-10-04
• Study First Submitted: 2019-04-12
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-20
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22
• Primary Completion: 2021-06
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

• Contraindication to MRI scanning
• Unable to give consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of brain injury assessed by Magnetic resonance imaging (MRI) test	Pre-operative and post-operative up to 6 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St Mary's Hospital; 🇬🇧 London, United Kingdom