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Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy (ProFATE)

Primary Purpose

Stroke, Occlusion, Cerebrovascular

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Endovascular thrombectomy
Sponsored by
Nottingham University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Large vessel occlusion, Balloon guide catheter, Flow arrest, Mechanical thrombectomy, Endovascular thrombectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nottingham University Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balloon inflation

No balloon inflation

Arm Description

Endovascular thrombectomy with simultaneous balloon inflation using a balloon guide catheter

Endovascular thrombectomy without simultaneous balloon inflation using a balloon guide catheter

Outcomes

Primary Outcome Measures

Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3
Near complete-complete vessel recanalisation

Secondary Outcome Measures

Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3
Successful vessel recanalisation
First pass effect (mTICI2c-3)
Near complete-complete vessel recanalisation after the first pass attempt at clot retrieval
New or distal vascular territory clot embolisation
Modified Rankin Scale 0-2
Good functional outcome based on the modified Rankin scale of disability
Symptomatic intracranial haemorrhage
National Institutes of Health of Stroke Scale (NIHSS)
Change in stroke severity
Mortality
Total number of passes at clot retrieval
Procedure related complications
Total procedural time

Full Information

First Posted
August 20, 2021
Last Updated
October 21, 2021
Sponsor
Nottingham University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05020795
Brief Title
Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy
Acronym
ProFATE
Official Title
Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Occlusion, Cerebrovascular
Keywords
Stroke, Large vessel occlusion, Balloon guide catheter, Flow arrest, Mechanical thrombectomy, Endovascular thrombectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balloon inflation
Arm Type
Experimental
Arm Description
Endovascular thrombectomy with simultaneous balloon inflation using a balloon guide catheter
Arm Title
No balloon inflation
Arm Type
Active Comparator
Arm Description
Endovascular thrombectomy without simultaneous balloon inflation using a balloon guide catheter
Intervention Type
Procedure
Intervention Name(s)
Endovascular thrombectomy
Intervention Description
Clot retrieval for large vessel occlusion in acute ischaemic stroke
Primary Outcome Measure Information:
Title
Modified thrombolysis in cerebral infarction (mTICI) score of 2c-3
Description
Near complete-complete vessel recanalisation
Time Frame
Immediately after endovascular thrombectomy
Secondary Outcome Measure Information:
Title
Modified thrombolysis in cerebral infarction (mTICI) score of 2b-3
Description
Successful vessel recanalisation
Time Frame
Immediately after endovascular thrombectomy
Title
First pass effect (mTICI2c-3)
Description
Near complete-complete vessel recanalisation after the first pass attempt at clot retrieval
Time Frame
During endovascular thrombectomy procedure
Title
New or distal vascular territory clot embolisation
Time Frame
Immediately after endovascular thrombectomy
Title
Modified Rankin Scale 0-2
Description
Good functional outcome based on the modified Rankin scale of disability
Time Frame
90 days
Title
Symptomatic intracranial haemorrhage
Time Frame
24 hours after Endovascular thrombectomy
Title
National Institutes of Health of Stroke Scale (NIHSS)
Description
Change in stroke severity
Time Frame
24 hours
Title
Mortality
Time Frame
90 days
Title
Total number of passes at clot retrieval
Time Frame
Immediately after endovascular thrombectomy
Title
Procedure related complications
Time Frame
Immediately after endovascular thrombectomy
Title
Total procedural time
Time Frame
Immediately after endovascular thrombectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Permesh Singh Dhillon
Phone
01159249924
Email
permesh.dhillon@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Permesh Singh Dhillon
Organizational Affiliation
Nottingham University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Permesh Singh Dhillon
Phone
01159249924
Email
permesh.dhillon@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Effect of Proximal Blood Flow Arrest During Endovascular Thrombectomy

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