Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

Nottingham University Hospitals NHS Trust1 site in 1 country134 target enrollmentOctober 7, 2021

ConditionsStroke Occlusion, Cerebrovascular

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Nottingham University Hospitals NHS Trust
Enrollment: 134
Locations: 1
Primary Endpoint: Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 7, 2021

End Date

November 1, 2023

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nottingham University Hospitals NHS Trust

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: Immediately after endovascular thrombectomy

Near complete-complete vessel recanalisation

Secondary Outcomes

Symptomatic intracranial haemorrhage(24 hours after Endovascular thrombectomy)
Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3(Immediately after endovascular thrombectomy)
Mortality(90 days)
New or distal vascular territory clot embolisation(Immediately after endovascular thrombectomy)
National Institutes of Health of Stroke Scale (NIHSS)(24 hours)
First pass effect (mTICI2c-3)(During endovascular thrombectomy procedure)
Modified Rankin Scale 0-2(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)