Clinical trial NCT04062539: Total Cerebral Protection With Embolic Protection Devices Thoracic Aortic Stenting
Official title: Total Cerebral Protection With Embolic Protection Devices in Thoracic Aortic Stenting
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Stroke
Silent Cerebral Infarct
Keywords: stroke
cerebral embolic protection device
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: St Mary's Hospital, London
First posted: 2019-08-20
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care; elective patients from an outpatient clinical bases and emergency patients presenting through Accident and Emergency

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Contraindication to MRI scanning
* Unable to give consent

Primary outcomes:
measure: Incidence of brain injury assessed by Magnetic resonance imaging (MRI) test
timeFrame: Pre-operative and post-operative up to 6 months
Secondary outcomes:
measure: Incidence of embolic event
timeFrame: Intra-operative
measure: Changes in neurocognition function
timeFrame: Pre-operative and post-operative up until 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's Hospital
Study officials:
affiliation: Imperial College London
name: Richard Gibbs
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.