Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

Not Applicable

• Conditions: Occlusion, Cerebrovascular; Stroke
• Interventions: Procedure: Endovascular thrombectomy

• Registration Number: NCT05020795
• Lead Sponsor: Nottingham University Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-25
• Study Start: 2021-10-07
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-28
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No balloon inflation	Endovascular thrombectomy	Endovascular thrombectomy without simultaneous balloon inflation using a balloon guide catheter
Balloon inflation	Endovascular thrombectomy	Endovascular thrombectomy with simultaneous balloon inflation using a balloon guide catheter

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom