Total Cerebral Protection With Embolic Protection Devices Thoracic Aortic Stenting

NCT04062539 | Suspended

• 1 other identifier: INTERCEPT:CEPD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Silent Cerebral Infarct

Keywords

stroke; cerebral embolic protection device

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Incidence of embolic event

  Intra-operative

• Changes in neurocognition function

  Pre-operative and post-operative up until 6 months

Interventions

Sentinel and Spider DEVICE

Dual filter and single filter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary care; elective patients from an outpatient clinical bases and emergency patients presenting through Accident and Emergency

You may qualify if:

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

You may not qualify if:

• Contraindication to MRI scanning
• Unable to give consent

Sponsors & Collaborators

• Imperial College London: lead
• St Mary's Hospital, London: collaborator

Study Sites (1)

St Mary's Hospital

London, W21NY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29431856 BACKGROUND

• 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.

  PMID: 29804744 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

All captured material from the filters will be analysed and this can include atherosclerotic particles and thrombus.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Richard Gibbs

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: August 20, 2019
• Study Start: October 4, 2018
• Primary Completion: June 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)