Total Cerebral Protection With Embolic Protection Devices Thoracic Aortic Stenting

Stroke Clinical Trial

Official title:

Total Cerebral Protection With Embolic Protection Devices in Thoracic Aortic Stenting

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04062539
• Other study ID #: INTERCEPT:CEPD
• Status: Suspended
• Start date: October 4, 2018
• Est. completion date: November 2021

Study information

• Verified date: August 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: November 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Contraindication to MRI scanning

• Unable to give consent

Related Conditions & MeSH terms

• Cerebral Infarction
• Silent Cerebral Infarct
• Stroke

Intervention

Device:
• Sentinel and Spider
Dual filter and single filter

Locations

Country	Name	City	State
United Kingdom	St Mary's Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	St Mary's Hospital, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of embolic event	Transcranial doppler monitoring of embolic events	Intra-operative
Secondary	Changes in neurocognition function	Neurocognitive tests to assess the changes in neurocognition function	Pre-operative and post-operative up until 6 months