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OpenTrials
Completed

NCT Number: NCT05020795

Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Occlusion, Cerebrovascular Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endovascular Thrombectomy

Procedure

Clot retrieval for large vessel occlusion in acute ischaemic stroke

Primary outcomes

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

    Time frame: Immediately after endovascular thrombectomy

    Near complete-complete vessel recanalisation

Secondary outcomes

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

    Time frame: Immediately after endovascular thrombectomy

    Successful vessel recanalisation

  2. First pass effect (mTICI2c-3)

    Time frame: During endovascular thrombectomy procedure

    Near complete-complete vessel recanalisation after the first pass attempt at clot retrieval

  3. New or distal vascular territory clot embolisation

    Time frame: Immediately after endovascular thrombectomy

  4. Modified Rankin Scale 0-2

    Time frame: 90 days

    Good functional outcome based on the modified Rankin scale of disability

  5. Symptomatic intracranial haemorrhage

    Time frame: 24 hours after Endovascular thrombectomy

  6. National Institutes of Health of Stroke Scale (NIHSS)

    Time frame: 24 hours

    Change in stroke severity

  7. Mortality

    Time frame: 90 days

  8. Total number of passes at clot retrieval

    Time frame: Immediately after endovascular thrombectomy

  9. Procedure related complications

    Time frame: Immediately after endovascular thrombectomy

  10. Total procedural time

    Time frame: Immediately after endovascular thrombectomy

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Registry information

Acronym: ProFATE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2021
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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