Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

Stroke Clinical Trial

— ProFATE  

Official title:

Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05020795
• Other study ID #: 21DI004
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2021
• Source: Nottingham University Hospitals NHS Trust
• Contact: Permesh Singh Dhillon
• Phone: 01159249924
• Email: permesh.dhillon[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Occlusion, Cerebrovascular
• Stroke

Intervention

Procedure:
• Endovascular thrombectomy
Clot retrieval for large vessel occlusion in acute ischaemic stroke

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3	Near complete-complete vessel recanalisation	Immediately after endovascular thrombectomy
Secondary	Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3	Successful vessel recanalisation	Immediately after endovascular thrombectomy
Secondary	First pass effect (mTICI2c-3)	Near complete-complete vessel recanalisation after the first pass attempt at clot retrieval	During endovascular thrombectomy procedure
Secondary	New or distal vascular territory clot embolisation		Immediately after endovascular thrombectomy
Secondary	Modified Rankin Scale 0-2	Good functional outcome based on the modified Rankin scale of disability	90 days
Secondary	Symptomatic intracranial haemorrhage		24 hours after Endovascular thrombectomy
Secondary	National Institutes of Health of Stroke Scale (NIHSS)	Change in stroke severity	24 hours
Secondary	Mortality		90 days
Secondary	Total number of passes at clot retrieval		Immediately after endovascular thrombectomy
Secondary	Procedure related complications		Immediately after endovascular thrombectomy
Secondary	Total procedural time		Immediately after endovascular thrombectomy