INTERvention with Cerebral Embolic Protection in TEVAR:INTERCEPT (V1)
Research type
Research Study
Full title
Carbon-Dioxide versus Saline flushing of thoracic aortic stent-grafts to Reduce Neurological Injury: A Pilot Randomised Controlled Trial
IRAS ID
262145
Contact name
Richard Gibbs
Contact email
Sponsor organisation
Imperial College
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Carbon-Dioxide Flushing versus Saline Flushing of Aortic Stents to Reduce Brain Injury and Stroke from Thoracic Aortic Endovascular Repair (TEVAR): A Pilot Randomised Controlled Trial
Disease of the thoracic aorta (a major blood vessel in the chest that supplies the whole body)are rare but cause 5,000 deaths each year from internal bleeding if the patient doesn’t receive urgent surgery in a specialist hospital. Traditionally, surgery involves a large cut to the rib-cage to fix the blood vessel, but this is a very risky operation, especially in older patients, with only 50% of patients surviving. A new surgery called thoracic aortic endovascular repair (TEVAR) is key-hole surgery to fix the blood vessel from the inside with a mesh tube. It is the preferred way to fix the blood vessel because more people survive and have better outcomes than with major surgery.
However, 4 out of 5 patients who undergo this life-saving procedure are left with brain damage that causes stroke and problems with memory, affecting their everyday life activities. Brain damage is the result of air bubbles released from the tube that damage the brain. Air bubbles are normally removed from the tube by flushing with salty water (saline). Carbon-dioxide (CO2, a gas that we breathe out) may be a better way of removing the air and preventing brain damage.
Patients eligible for TEVAR at vascular hospitals will be randomly allocated to undergo TEVAR with a saline or CO2 flush. They will have a brain scan, physical examination and tests of memory before and after surgery to look for brain injury, and non-invasive monitoring of the blood flow to the brain during surgery to look for air bubbles. The study will last for 24 months and will allow us to determine which flush is better at removing air and preventing brain damage.
REC name
London - Fulham Research Ethics Committee
REC reference
19/LO/0836
Date of REC Opinion
29 May 2019
REC opinion
Favourable Opinion