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Intervention With Cerebral Embolic Protection in TEVAR: Gaseous Protection

NCT03886675 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-10-23

No results posted yet for this study

Summary

Vascular brain infarction (VBI) occurs in 67% of patients undergoing TEVAR. Overt stroke occurs in 13% of these patients and 88% of patients suffer from neurocognitive impairment.

Cerebral air embolisation during the stent-graft deployment phase of TEVAR may be a cause of VBI. Standard treatment to de-air stent-grafts is through the use of a saline flush.

This study aims to investigate whether carbon-dioxide or saline is the better fluid to de-air TEVAR stent-grafts prior to insertion in to the patient and compare VBI rate in the carbon-dioxide group and saline group.

Conditions

  • Stroke
  • Silent Cerebral Infarction
  • Neurocognitive Dysfunction
  • Vascular Brain Injury

Interventions

OTHER

CO2 flushing

As above

OTHER

Saline flushing

As above

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • St George's University Hospitals NHS Foundation Trust

    collaborator OTHER

  • University Hospitals Coventry and Warwickshire NHS Trust

    collaborator OTHER

  • South Canterbury DHB, New Zealand

    collaborator UNKNOWN

  • Baylor Scott and White Health

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • Health New Zealand

    collaborator UNKNOWN

  • Imperial College London

    lead OTHER

Principal Investigators

  • Richard Gibbs · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2024-06-06
Completion
2024-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03886675 on ClinicalTrials.gov