StrokeINTERCEPT:GPNCT03886675
Intervention With Cerebral Embolic Protection in TEVAR: Gaseous Protection
A study testing CO2 flushing and Saline flushing in people with Stroke and Silent Cerebral Infarction, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Silent Cerebral Infarction, Neurocognitive Dysfunction
- What is being tested?
- CO2 flushing and Saline flushing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Nov 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants suitable for TEVAR with capacity to consent
Who cannot join
- Participants who lack capacity to consent
- Contraindications to MRI such as pacemaker
- Pregnant participants
- Participants who do not wish to participate
- Participants <18yrs
Trial locations and contacts
1 site in 1 country.
Richard Gibbs contact
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London
London, W2 1NY
Ruth Nicholson, r.nicholson@imperial.ac.uk
About this study
Official title: Carbon-Dioxide Flushing Versus Saline Flushing in Thoracic Endovascular Aortic Repair to Reduce Neurological Injury: A Pilot Randomised Controlled Trial
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.
Read the detailed description
Thoracic endovascular aortic repair (TEVAR) is the re-lining of the thoracic aorta to prevent life threatening haemorrhage and death from rupture. This involves a small cut in the femoral artery in the groin and under imaging guidance, the insertion of wires and a stent into the thoracic aorta.
Prior to insertion into the patient, stents are flushed with saline to remove air and prevent air reaching the brain that can cause a form of brain injury known as vascular brain infarction (VBI). However, our preliminary clinical data suggests that saline flushing is not effective at de-airing stent-grafts used in TEVAR.
Carbon-dioxide has been used extensively in cardiac surgery to displace air from the chest cavity to prevent peri-procedural cerebral air embolisation. We hypothesise that flushing the stent-grafts with carbon-dioxide may be better at removing air from the stent-grafts than saline flush.
Patients undergoing TEVAR will be approached to participate in this study. After written consent is obtained, participants will be randomised to undergo (TEVAR) with carbon dioxide or saline flushing of stent-grafts. Pre-operatively, participants will undergo extensive neurocognitive testing, and a baseline blood test. Intra-operatively, participants will undergo continuous transcranial doppler monitoring (TCD) of the middle cerebral artery (MCA) to look for cerebral air embolisation at stent-graft deployment phase of TEVAR. Blood testing pre-op, immediately post op, and 24 hours post op will be taken to measure for biomarkers of brain injury. Post-operatively, participants will undergo another diffusion-weighted brain MRI within 72 hours post-procedure, stroke and delirium assessment at day 1, 3 and day 7 +/- day of discharge, and at 6-weeks and 6-month follow-up.
- Being tested
- CO2 flushing, Saline flushing
- Keywords
- Stroke, Silent cerebral infarction, Carbon dioxide, Thoracic endovascular aortic repair, TEVAR, DW-MRI, Vascular brain infarction
- Medical subject headings
- Stroke, Cognition Disorders, Cerebrovascular Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 flushingOther
As above
Saline flushingOther
As above
| Study group | Role | What they receive |
|---|---|---|
| carbon-dioxide | Experimental | Flushing of stent-grafts in TEVAR with carbon-dioxide Receives: Other: CO2 flushing |
| Saline | Active comparator | Flushing of stent-grafts with saline Receives: Other: Saline flushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
The number of patients recruited into the trial will be collected
Measured: 36 months
Retention
The proportion of patients undergoing follow-up assessments will be collected
Measured: 36 months
Study design for full randomised controlled trial
The proportion of patients who are eligible for the trial will be collected
Measured: 36 months
Secondary outcomes (6)
Number, size and location of new ischaemic lesions on post-operative diffusion-weighted MRI scans
Using DW-MRI at <72 hours post operatively (day 1-7), and also 6 months post operatively, we will assess for new ischaemic lesions
Measured: 36 months
Number of gaseous and solid intra-operative transcranial doppler microembolic signals by phase of TEVAR
At all London units, transcranial doppler insonation of the middle cerebral artery will be carried out during the procedure, and analysed offline at a later date to evaluate gaseous or solid emboli during TEVAR
Measured: Duration of surgery, 36 months collection
Number of participants with stroke or delirium as an inpatient
Patients will undergo stroke and delirium assessment.
Measured: These will be carried out within 48 hours of patients' return to level 1 care. 36 months collection
Serial biomarker blood tests
Blood samples will be taken preoperatively, at the end of the procedure and 24 hours late. These will be analysed for a biomarker of neuroglial injury, S100B
Measured: 36 months
Risk factor assessment
Data such as stent type will be collected.
Measured: 36 months
Neurological assessment, delirium assessment and quality of life testing
Patients will undergo a baseline neurocognitive, delirium and quality of life testing. These will be repeated as an outpatient to measure change post operatively.
Measured: Pre-op, first outpatient assessment (approximately 6 weeks), 6 months. 36 months collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start14 Nov 2022
- Primary completion6 Jun 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomisation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Guy's and St Thomas' NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, South Canterbury DHB, New Zealand, Baylor Scott and White Health, University Hospital Southampton NHS Foundation Trust, Health New Zealand
- Responsible party
- Sponsor
- Investigators
- Richard Gibbs, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886675
- Sponsor's protocol ID
- INTERCEPT:GP
- Acronym
- INTERCEPT:GP
- Status last verified
- Oct 2023
- First submitted
- 20 Mar 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data requests can be made to the corresponding author and make on a case by case basis
Publications
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.
PubMed 29431856Kahlert 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.
PubMed 24841546Masada 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.
PubMed 30629169Inci 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.
PubMed 27994872Rohlffs 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.
PubMed 27798380Martens 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.
PubMed 18222261Ganguly 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.
PubMed 25939908Bismuth 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.
PubMed 21371850Crockett 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.
PubMed 37105705
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon-Dioxide Flushing Versus Saline Flushing in Thoracic Endovascular Aortic Repair to Reduce Neurological Injury: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03886675
- Acronym / sponsor ID
- INTERCEPT:GP / INTERCEPT:GP
- Keywords
- Stroke, Silent cerebral infarction, Carbon dioxide, Thoracic endovascular aortic repair, TEVAR, DW-MRI, Vascular brain infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, Guy's and St Thomas' NHS Foundation Trust, St George's University Hospitals NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, South Canterbury DHB, New Zealand, Baylor Scott and White Health, University Hospital Southampton NHS Foundation Trust, Health New Zealand
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 6 Jun 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Thoracic endovascular aortic repair (TEVAR) is the re-lining of the thoracic aorta to prevent life threatening haemorrhage and death from rupture. This involves a small cut in the femoral artery in the groin and under imaging guidance, the insertion of wires and a stent into the thoracic aorta.
Prior to insertion into the patient, stents are flushed with saline to remove air and prevent air reaching the brain that can cause a form of brain injury known as vascular brain infarction (VBI). However, our preliminary clinical data suggests that saline flushing is not effective at de-airing stent-grafts used in TEVAR.
Carbon-dioxide has been used extensively in cardiac surgery to displace air from the chest cavity to prevent peri-procedural cerebral air embolisation. We hypothesise that flushing the stent-grafts with carbon-dioxide may be better at removing air from the stent-grafts than saline flush.
Patients undergoing TEVAR will be approached to participate in this study. After written consent is obtained, participants will be randomised to undergo (TEVAR) with carbon dioxide or saline flushing of stent-grafts. Pre-operatively, participants will undergo extensive neurocognitive testing, and a baseline blood test. Intra-operatively, participants will undergo continuous transcranial doppler monitoring (TCD) of the middle cerebral artery (MCA) to look for cerebral air embolisation at stent-graft deployment phase of TEVAR. Blood testing pre-op, immediately post op, and 24 hours post op will be taken to measure for biomarkers of brain injury. Post-operatively, participants will undergo another diffusion-weighted brain MRI within 72 hours post-procedure, stroke and delirium assessment at day 1, 3 and day 7 +/- day of discharge, and at 6-weeks and 6-month follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomisation
| Arm | Type | Receives |
|---|---|---|
| carbon-dioxide | Experimental | Other: CO2 flushingFlushing of stent-grafts in TEVAR with carbon-dioxide |
| Saline | Active comparator | Other: Saline flushingFlushing of stent-grafts with saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants suitable for TEVAR with capacity to consent
Key exclusion criteria (5 listed)
- Participants who lack capacity to consent
- Contraindications to MRI such as pacemaker
- Pregnant participants
- Participants who do not wish to participate
- Participants <18yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 flushingAs above | Other | carbon-dioxide |
| Saline flushingAs above | Other | Saline |
Primary outcome
Recruitment
Time frame: 36 months
The number of patients recruited into the trial will be collected
Retention
Time frame: 36 months
The proportion of patients undergoing follow-up assessments will be collected
Study design for full randomised controlled trial
Time frame: 36 months
The proportion of patients who are eligible for the trial will be collected
6 secondary outcomes
Number, size and location of new ischaemic lesions on post-operative diffusion-weighted MRI scans
Time frame: 36 months
Number of gaseous and solid intra-operative transcranial doppler microembolic signals by phase of TEVAR
Time frame: Duration of surgery, 36 months collection
Number of participants with stroke or delirium as an inpatient
Time frame: These will be carried out within 48 hours of patients' return to level 1 care. 36 months collection
Serial biomarker blood tests
Time frame: 36 months
Risk factor assessment
Time frame: 36 months
Neurological assessment, delirium assessment and quality of life testing
Time frame: Pre-op, first outpatient assessment (approximately 6 weeks), 6 months. 36 months collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 29431856Perera 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.
- Background: PubMed 24841546Kahlert 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.
- Background: PubMed 30629169Masada 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.
- Background: PubMed 27994872Inci 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.
- Background: PubMed 27798380Rohlffs 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.
- Background: PubMed 18222261Martens 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.
- Background: PubMed 25939908Ganguly 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.
- Background: PubMed 21371850Bismuth 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.
- Derived from this study: PubMed 37105705Crockett 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.
- Individual participant dataSharing planned: Yes. Data requests can be made to the corresponding author and make on a case by case basis
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Gibbs contact
Richard Gibbs principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 flushing and Saline flushing in people with Stroke and Silent Cerebral Infarction, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lydia Hanna (07747002704, l.hanna@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03886675, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.