Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy (ProFATE)

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 Overview

• Status: Completed
• Conditions: Stroke; Occlusion, Cerebrovascular
• Intervention / Treatment: Procedure: Endovascular thrombectomy

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals Nhs Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balloon inflation; Endovascular thrombectomy with simultaneous balloon inflation using a balloon guide catheter	Procedure: Endovascular thrombectomy; Clot retrieval for large vessel occlusion in acute ischaemic stroke
Active Comparator: No balloon inflation; Endovascular thrombectomy without simultaneous balloon inflation using a balloon guide catheter	Procedure: Endovascular thrombectomy; Clot retrieval for large vessel occlusion in acute ischaemic stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3	Near complete-complete vessel recanalisation	Immediately after endovascular thrombectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		90 days
Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3	Successful vessel recanalisation	Immediately after endovascular thrombectomy
First pass effect (mTICI2c-3)	Near complete-complete vessel recanalisation after the first pass attempt at clot retrieval	During endovascular thrombectomy procedure
New or distal vascular territory clot embolisation		Immediately after endovascular thrombectomy
Modified Rankin Scale 0-2	Good functional outcome based on the modified Rankin scale of disability	90 days
Symptomatic intracranial haemorrhage		24 hours after Endovascular thrombectomy
National Institutes of Health of Stroke Scale (NIHSS)	Change in stroke severity	24 hours
Total number of passes at clot retrieval		Immediately after endovascular thrombectomy
Procedure related complications		Immediately after endovascular thrombectomy
Total procedural time		Immediately after endovascular thrombectomy

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Investigators: Principal Investigator: Permesh Singh Dhillon, Nottingham University Hospitals Nhs Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Large vessel occlusion; Mechanical thrombectomy; Endovascular thrombectomy; Balloon guide catheter; Flow arrest
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: 21DI004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No