Intervention With Cerebral Embolic Protection in TEVAR: Gaseous Protection

NCT03886675 | Unknown

• 1 other identifier: INTERCEPT:GP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stroke; Silent cerebral infarction; Carbon dioxide; Thoracic endovascular aortic repair; TEVAR; DW-MRI; Vascular brain infarction

Outcome Measures

Primary Outcomes (3)

• Recruitment

  The number of patients recruited into the trial will be collected

  36 months

• Retention

  The proportion of patients undergoing follow-up assessments will be collected

  36 months

• Study design for full randomised controlled trial

  The proportion of patients who are eligible for the trial will be collected

  36 months

Secondary Outcomes (6)

• Number, size and location of new ischaemic lesions on post-operative diffusion-weighted MRI scans

  36 months

• Number of gaseous and solid intra-operative transcranial doppler microembolic signals by phase of TEVAR

  Duration of surgery, 36 months collection

• Number of participants with stroke or delirium as an inpatient

  These will be carried out within 48 hours of patients' return to level 1 care. 36 months collection

• Serial biomarker blood tests

  36 months

• Risk factor assessment

  36 months

Study Arms (2)

carbon-dioxide

EXPERIMENTAL

Flushing of stent-grafts in TEVAR with carbon-dioxide

Other: CO2 flushing

Saline

ACTIVE COMPARATOR

Flushing of stent-grafts with saline

Other: Saline flushing

Interventions

CO2 flushing OTHER

As above

carbon-dioxide

Saline flushing OTHER

As above

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants suitable for TEVAR with capacity to consent

You may not qualify if:

• Participants who lack capacity to consent
• Contraindications to MRI such as pacemaker
• Pregnant participants
• Participants who do not wish to participate
• Participants \<18yrs

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• St George's University Hospitals NHS Foundation Trust: collaborator
• University Hospitals Coventry and Warwickshire NHS Trust: collaborator
• South Canterbury DHB, New Zealand: collaborator
• Baylor Scott and White Health: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Health New Zealand: collaborator

Study Sites (1)

Imperial College London

London, W2 1NY, United Kingdom

RECRUITING

Related Publications (9)

• 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

• Kahlert P, Eggebrecht H, Janosi RA, Hildebrandt HA, Plicht B, Tsagakis K, Moenninghoff C, Nensa F, Mummel P, Heusch G, Jakob HG, Forsting M, Erbel R, Schlamann M. Silent cerebral ischemia after thoracic endovascular aortic repair: a neuroimaging study. Ann Thorac Surg. 2014 Jul;98(1):53-8. doi: 10.1016/j.athoracsur.2014.03.037. Epub 2014 May 17.

  PMID: 24841546 BACKGROUND

• Masada K, Kuratani T, Shimamura K, Kin K, Shijo T, Goto T, Sawa Y. Silent cerebral infarction after thoracic endovascular aortic repair: a magnetic resonance imaging study. Eur J Cardiothorac Surg. 2019 Jun 1;55(6):1071-1078. doi: 10.1093/ejcts/ezy449.

  PMID: 30629169 BACKGROUND

• Inci K, Koutouzi G, Chernoray V, Jeppsson A, Nilsson H, Falkenberg M. Air bubbles are released by thoracic endograft deployment: An in vitro experimental study. SAGE Open Med. 2016 Dec 7;4:2050312116682130. doi: 10.1177/2050312116682130. eCollection 2016.

  PMID: 27994872 BACKGROUND

• Rohlffs F, Tsilimparis N, Saleptsis V, Diener H, Debus ES, Kolbel T. Air Embolism During TEVAR: Carbon Dioxide Flushing Decreases the Amount of Gas Released from Thoracic Stent-Grafts During Deployment. J Endovasc Ther. 2017 Feb;24(1):84-88. doi: 10.1177/1526602816675621. Epub 2016 Oct 26.

  PMID: 27798380 BACKGROUND

• Martens S, Neumann K, Sodemann C, Deschka H, Wimmer-Greinecker G, Moritz A. Carbon dioxide field flooding reduces neurologic impairment after open heart surgery. Ann Thorac Surg. 2008 Feb;85(2):543-7. doi: 10.1016/j.athoracsur.2007.08.047.

  PMID: 18222261 BACKGROUND

• Ganguly G, Dixit V, Patrikar S, Venkatraman R, Gorthi SP, Tiwari N. Carbon dioxide insufflation and neurocognitive outcome of open heart surgery. Asian Cardiovasc Thorac Ann. 2015 Sep;23(7):774-80. doi: 10.1177/0218492315583562. Epub 2015 May 4.

  PMID: 25939908 BACKGROUND

• Bismuth J, Garami Z, Anaya-Ayala JE, Naoum JJ, El Sayed HF, Peden EK, Lumsden AB, Davies MG. Transcranial Doppler findings during thoracic endovascular aortic repair. J Vasc Surg. 2011 Aug;54(2):364-9. doi: 10.1016/j.jvs.2010.12.063. Epub 2011 Mar 3.

  PMID: 21371850 BACKGROUND

• Crockett S, Hanna L, Singh A, Gunning S, Nicholas R, Bicknell C, Hamady M, Gable D, Sallam M, Modarai B, Abisi S, Lyons O, Gibbs R. Carbon dioxide flushing versus saline flushing of thoracic aortic stents (INTERCEPTevar): protocol for a multicentre pilot randomised controlled trial. BMJ Open. 2023 Apr 27;13(4):e067605. doi: 10.1136/bmjopen-2022-067605.

  PMID: 37105705 DERIVED

MeSH Terms

Conditions

Stroke; Cognition Disorders; Cerebrovascular Trauma

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Richard Gibbs

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydia Hanna

CONTACT

07747002704; l.hanna@imperial.ac.uk

Richard Gibbs

CONTACT

r.gibbs@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to treatment allocation. Assessment of TCD embolic data, DW-MRI scan reporting and neurological and neurocognitive assessment will be carried out by blinded trained assessors.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomisation

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 22, 2019
• Study Start: November 14, 2022
• Primary Completion: June 6, 2024
• Study Completion: October 1, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 10 years
• Access Criteria: These will be reviewed on a case by case basis

Locations

GB (1)