Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

Conditions
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Stroke, Occlusion, Cerebrovascular

Intervention / Treatment
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* Procedure: Endovascular thrombectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Large vessel occlusion, Balloon guide catheter, Flow arrest, Mechanical thrombectomy, Endovascular thrombectomy