Total Cerebral Protection With Embolic Protection Devices Thoracic Aortic Stenting

NCT ID: NCT04062539

Last Updated: 2019-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-04

Study Completion Date

2021-11-30

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.

Conditions

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Stroke Silent Cerebral Infarct

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Sentinel and Spider

Dual filter and single filter

Intervention Type DEVICE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St Mary's Hospital, London

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Gibbs

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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St Mary's Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 29431856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29804744 (View on PubMed)

Other Identifiers

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INTERCEPT:CEPD

Identifier Type: -

Identifier Source: org_study_id

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