StrokeProFATENCT05020795
Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy
A study testing Endovascular thrombectomy in people with Stroke and Occlusion, Cerebrovascular, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Endovascular thrombectomy (EVT) has become the standard of care for large vessel occlusion in acute ischaemic stroke (AIS). During clot-retrieval, simultaneous balloon inflation within the internal carotid artery offers transient proximal blood flow arrest, potentially preventing distal clot migration or embolisation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Occlusion, Cerebrovascular
- What is being tested?
- Endovascular thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Oct 2021to 1 Nov 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Acute ischemic stroke presenting with a neurological deficit of (NIHSS ≥2)
- Intracranial arterial occlusion of the distal internal carotid artery or middle cerebral artery (M1/M2 segments) demonstrated with on clinical neuroimaging such as: computed tomography angiogram (CTA), magnetic resonance imaging angiogram (MRA), or digital subtraction angiography (DSA).
- ASPECTS score of >4 or by locally accepted ischaemic core/penumbra mismatch using computed tomography perfusion or magnetic resonance (CTP or MR) imaging.
- modified Rankin Scale, mRS<3
- Intention to treat with aspiration only or combination technique of stent-retriever + aspiration in the first pass attempt during endovascular thrombectomy
Who cannot join
- Severe stenosis (>90%), or tandem occlusion of the ipsilateral extracranial internal carotid artery.
- Previously deployed stents in the ipsilateral internal carotid artery.
- Dissections of the ipsilateral internal carotid artery.
- Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
- Subject participating in a study involving an investigational drug or device that would impact this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
About this study
Endovascular thrombectomy (EVT) has become the standard of care for large vessel occlusion in acute ischaemic stroke (AIS). During clot-retrieval, simultaneous balloon inflation within the internal carotid artery offers transient proximal blood flow arrest, potentially preventing distal clot migration or embolisation to new vascular territories. Retrospective studies indicate that this may improve complete vessel recanalisation rates and may translate to improved functional independence. However, lack of high-quality evidence demonstrating the efficacy of simultaneous balloon inflation has led to clinical equipoise with heterogeneity of practice globally.
- Conditions
- Stroke, Occlusion, Cerebrovascular
- Being tested
- Endovascular thrombectomy
- Keywords
- Stroke, Large vessel occlusion, Balloon guide catheter, Flow arrest, Mechanical thrombectomy, Endovascular thrombectomy
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular thrombectomyProcedure or surgery
Clot retrieval for large vessel occlusion in acute ischaemic stroke
| Study group | Role | What they receive |
|---|---|---|
| Balloon inflation | Experimental | Endovascular thrombectomy with simultaneous balloon inflation using a balloon guide catheter Receives: Procedure: Endovascular thrombectomy |
| No balloon inflation | Active comparator | Endovascular thrombectomy without simultaneous balloon inflation using a balloon guide catheter Receives: Procedure: Endovascular thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3
Near complete-complete vessel recanalisation
Measured: Immediately after endovascular thrombectomy
Secondary outcomes (10)
Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3
Successful vessel recanalisation
Measured: Immediately after endovascular thrombectomy
First pass effect (mTICI2c-3)
Near complete-complete vessel recanalisation after the first pass attempt at clot retrieval
Measured: During endovascular thrombectomy procedure
New or distal vascular territory clot embolisation
Measured: Immediately after endovascular thrombectomy
Modified Rankin Scale 0-2
Good functional outcome based on the modified Rankin scale of disability
Measured: 90 days
Symptomatic intracranial haemorrhage
Measured: 24 hours after Endovascular thrombectomy
National Institutes of Health of Stroke Scale (NIHSS)
Change in stroke severity
Measured: 24 hours
Mortality
Measured: 90 days
Total number of passes at clot retrieval
Measured: Immediately after endovascular thrombectomy
Procedure related complications
Measured: Immediately after endovascular thrombectomy
Total procedural time
Measured: Immediately after endovascular thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start7 Oct 2021
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Permesh Singh Dhillon, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020795
- Sponsor's protocol ID
- 21DI004
- Acronym
- ProFATE
- Status last verified
- Jun 2025
- First submitted
- 20 Aug 2021
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Dhillon PS, Butt W, Podlasek A, Bhogal P, Lynch J, Booth TC, McConachie N, Lenthall R, Nair S, Malik L, Goddard T, Carraro do Nascimento V, Barrett E, Jethwa K, Krishnan K, Dineen RA, England TJ; ProFATE Investigators. Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy (ProFATE): A Multicenter, Blinded-End Point, Randomized Clinical Trial. Stroke. 2025 Feb;56(2):371-379. doi: 10.1161/STROKEAHA.124.049715. Epub 2024 Dec 19.
PubMed 39697177Dhillon PS, Butt W, Podlasek A, Bhogal P, McConachie N, Lenthall R, Nair S, Malik L, Lynch J, Goddard T, Barrett E, Krishnan K, Dineen RA, England TJ. Effect of proximal blood flow arrest during endovascular thrombectomy (ProFATE): Study protocol for a multicentre randomised controlled trial. Eur Stroke J. 2023 Jun;8(2):581-590. doi: 10.1177/23969873231166194. Epub 2023 Mar 30.
PubMed 37231682
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy
- ClinicalTrials.gov ID
- NCT05020795
- Acronym / sponsor ID
- ProFATE / 21DI004
- Conditions
- Stroke, Occlusion, Cerebrovascular
- Keywords
- Stroke, Large vessel occlusion, Balloon guide catheter, Flow arrest, Mechanical thrombectomy, Endovascular thrombectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 25 Aug 2021 (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.
Endovascular thrombectomy (EVT) has become the standard of care for large vessel occlusion in acute ischaemic stroke (AIS). During clot-retrieval, simultaneous balloon inflation within the internal carotid artery offers transient proximal blood flow arrest, potentially preventing distal clot migration or embolisation to new vascular territories. Retrospective studies indicate that this may improve complete vessel recanalisation rates and may translate to improved functional independence. However, lack of high-quality evidence demonstrating the efficacy of simultaneous balloon inflation has led to clinical equipoise with heterogeneity of practice globally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon inflation | Experimental | Procedure: Endovascular thrombectomyEndovascular thrombectomy with simultaneous balloon inflation using a balloon guide catheter |
| No balloon inflation | Active comparator | Procedure: Endovascular thrombectomyEndovascular thrombectomy without simultaneous balloon inflation using a balloon guide catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Acute ischemic stroke presenting with a neurological deficit of (NIHSS ≥2)
- Intracranial arterial occlusion of the distal internal carotid artery or middle cerebral artery (M1/M2 segments) demonstrated with on clinical neuroimaging such as: computed tomography angiogram (CTA), magnetic resonance imaging angiogram (MRA), or digital subtraction angiography (DSA).
- ASPECTS score of >4 or by locally accepted ischaemic core/penumbra mismatch using computed tomography perfusion or magnetic resonance (CTP or MR) imaging.
- modified Rankin Scale, mRS<3
Key exclusion criteria (5 listed)
- Severe stenosis (>90%), or tandem occlusion of the ipsilateral extracranial internal carotid artery.
- Previously deployed stents in the ipsilateral internal carotid artery.
- Dissections of the ipsilateral internal carotid artery.
- Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).
- Subject participating in a study involving an investigational drug or device that would impact this study.
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 |
|---|---|---|
| Endovascular thrombectomyClot retrieval for large vessel occlusion in acute ischaemic stroke | Procedure or surgery | Balloon inflation, No balloon inflation |
Primary outcome
Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3
Time frame: Immediately after endovascular thrombectomy
Near complete-complete vessel recanalisation
10 secondary outcomes
Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3
Time frame: Immediately after endovascular thrombectomy
First pass effect (mTICI2c-3)
Time frame: During endovascular thrombectomy procedure
New or distal vascular territory clot embolisation
Time frame: Immediately after endovascular thrombectomy
Modified Rankin Scale 0-2
Time frame: 90 days
Symptomatic intracranial haemorrhage
Time frame: 24 hours after Endovascular thrombectomy
National Institutes of Health of Stroke Scale (NIHSS)
Time frame: 24 hours
Mortality
Time frame: 90 days
Total number of passes at clot retrieval
Time frame: Immediately after endovascular thrombectomy
Procedure related complications
Time frame: Immediately after endovascular thrombectomy
Total procedural time
Time frame: Immediately after endovascular thrombectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Derived from this study: PubMed 39697177Dhillon PS, Butt W, Podlasek A, Bhogal P, Lynch J, Booth TC, McConachie N, Lenthall R, Nair S, Malik L, Goddard T, Carraro do Nascimento V, Barrett E, Jethwa K, Krishnan K, Dineen RA, England TJ; ProFATE Investigators. Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy (ProFATE): A Multicenter, Blinded-End Point, Randomized Clinical Trial. Stroke. 2025 Feb;56(2):371-379. doi: 10.1161/STROKEAHA.124.049715. Epub 2024 Dec 19.
- Derived from this study: PubMed 37231682Dhillon PS, Butt W, Podlasek A, Bhogal P, McConachie N, Lenthall R, Nair S, Malik L, Lynch J, Goddard T, Barrett E, Krishnan K, Dineen RA, England TJ. Effect of proximal blood flow arrest during endovascular thrombectomy (ProFATE): Study protocol for a multicentre randomised controlled trial. Eur Stroke J. 2023 Jun;8(2):581-590. doi: 10.1177/23969873231166194. Epub 2023 Mar 30.
- Individual participant dataSharing planned: Yes
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.
Permesh Singh Dhillon principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular thrombectomy in people with Stroke and Occlusion, Cerebrovascular, run by Nottingham University Hospitals NHS Trust 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 6 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: finished, as of the sponsor's last update on 27 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3 (time frame: Immediately after endovascular thrombectomy). 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 NCT05020795, which also lists 2 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 27 Jun 2025.