Clinical trial NCT05020795: Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy
Official title: Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Occlusion, Cerebrovascular
Keywords: Stroke
Large vessel occlusion
Balloon guide catheter
Flow arrest
Mechanical thrombectomy
Endovascular thrombectomy
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3
timeFrame: Immediately after endovascular thrombectomy
Secondary outcomes:
measure: Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3
timeFrame: Immediately after endovascular thrombectomy
measure: First pass effect (mTICI2c-3)
timeFrame: During endovascular thrombectomy procedure
measure: New or distal vascular territory clot embolisation
timeFrame: Immediately after endovascular thrombectomy
measure: Modified Rankin Scale 0-2
timeFrame: 90 days
measure: Symptomatic intracranial haemorrhage
timeFrame: 24 hours after Endovascular thrombectomy
measure: National Institutes of Health of Stroke Scale (NIHSS)
timeFrame: 24 hours
measure: Mortality
timeFrame: 90 days
measure: Total number of passes at clot retrieval
timeFrame: Immediately after endovascular thrombectomy
measure: Procedure related complications
timeFrame: Immediately after endovascular thrombectomy
measure: Total procedural time
timeFrame: Immediately after endovascular thrombectomy
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Permesh Singh Dhillon
role: PRINCIPAL_INVESTIGATOR
References: