Occlusion, Cerebrovascular, Stroke
Conditions
Keywords
Stroke, Large vessel occlusion, Balloon guide catheter, Flow arrest, Mechanical thrombectomy, Endovascular thrombectomy
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.
Interventions
PROCEDUREEndovascular thrombectomy
Clot retrieval for large vessel occlusion in acute ischaemic stroke
Sponsors
Nottingham University Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3 | Immediately after endovascular thrombectomy | Near complete-complete vessel recanalisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3 | Immediately after endovascular thrombectomy | Successful vessel recanalisation |
| 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 | — |
| National Institutes of Health of Stroke Scale (NIHSS) | 24 hours | Change in stroke severity |
Countries
United Kingdom
Outcome results
None listed