Total Cerebral Protection With Embolic Protection Devices Thoracic Aortic Stenting

August 20, 2019 updated by: Imperial College London

Total Cerebral Protection With Embolic Protection Devices in Thoracic Aortic Stenting

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindication to MRI scanning
  • Unable to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of brain injury assessed by Magnetic resonance imaging (MRI) test
Time Frame: 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.
Pre-operative and post-operative up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

St Mary's Hospital, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

April 12, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INTERCEPT:CEPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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