ProFATE: Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

Sponsor

Nottingham University Hospitals NHS Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT05020795

Collaborator

(none)

124

Enrollment

Location

Arms

25.8

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Occlusion, Cerebrovascular	Procedure: Endovascular thrombectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

Actual Study Start Date :

Oct 7, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3 [Immediately after endovascular thrombectomy]
Near complete-complete vessel recanalisation

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.