Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

NCT05020795 | Completed DMC

• 1 other identifier: 21DI004
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Stroke; Large vessel occlusion; Balloon guide catheter; Flow arrest; Mechanical thrombectomy; Endovascular thrombectomy

Outcome Measures

Primary Outcomes (1)

• Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3

  Near complete-complete vessel recanalisation

  Immediately after endovascular thrombectomy

Secondary Outcomes (10)

• Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3

  Immediately after endovascular thrombectomy

• First pass effect (mTICI2c-3)

  During endovascular thrombectomy procedure

• New or distal vascular territory clot embolisation

  Immediately after endovascular thrombectomy

• Modified Rankin Scale 0-2

  90 days

• Symptomatic intracranial haemorrhage

  24 hours after Endovascular thrombectomy

Study Arms (2)

Balloon inflation

EXPERIMENTAL

Endovascular thrombectomy with simultaneous balloon inflation using a balloon guide catheter

Procedure: Endovascular thrombectomy

No balloon inflation

ACTIVE COMPARATOR

Endovascular thrombectomy without simultaneous balloon inflation using a balloon guide catheter

Procedure: Endovascular thrombectomy

Interventions

Endovascular thrombectomy PROCEDURE

Clot retrieval for large vessel occlusion in acute ischaemic stroke

Balloon inflation; No balloon inflation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39697177 DERIVED

• Dhillon 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.

  PMID: 37231682 DERIVED

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Permesh Singh Dhillon

  Nottingham University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 25, 2021
• Study Start: October 7, 2021
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)