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Evaluate Endovascular Treatment of Large Ischemic Stroke With Substantial Penumbra. (FrameLP)

Primary Purpose

Acute Ischemic Stroke

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endovascular treatment in addition of best medical treatment.
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute ischemic stroke, large stroke, Multimodal brain imaging, Thrombectomy, endovascular treatment

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients experiencing an acute ischemic stroke related to an anterior proximal large vessel occlusion (ICA/M1/Tandem) on MR or CT-angiography evolving for less than 24 hours from last known to be well. For patients experiencing a wake-up stroke or a stroke of unknown onset the mid-point between last seen well and symptoms discovery + the delay between symptoms discovery to randomization, will be used to calculate the delay between symptom onset to randomization.
  • On baseline imaging (MRI Diffusion Weighted Imaging/Perfusion Weighted Imaging or CTP) L.P. profile defined by a Large Core > 70 mL, and a MM ratio>1.4 using RAPID software.
  • Delay between end of imaging and randomization <90 min.
  • Expected delay between end of imaging and femoral puncture < 60 min
  • Best medical treatment including IV thrombolysis if indicated
  • Surrogate decision maker's consent or emergency inclusion form.
  • Affiliated person or beneficiary of a social security scheme.

Exclusion Criteria:

  • Pre-Stroke mRS >1.
  • Other serious advanced or terminal illness or life expectancy is estimated to be less than 6 months.
  • Pre-existing medical, neurological or psychiatric condition that would confound the neurological or functional evaluation.
  • Pregnancy and breastfeeding
  • Inability to undergo contrast brain perfusion MR or CT.
  • Technically inadequate perfusion imaging precluding L.P. profile assessment
  • Occlusion in multiple proximal vascular site territories (eg. bilateral anterior circulation occlusion or anterior + posterior circulation occlusions).
  • Known allergy to iodine precluding EVT.
  • Vessel anatomy or tortuosity precluding EVT.
  • Patient under judicial protection.
  • Participation in another interventional or therapeutic study

Sites / Locations

  • Hôpital Pellegrin
  • University Hospital of Lille Hôpital Roger Salengro
  • University Hospital of Limoges Hôpital Dupuytren 1
  • University Hospital of Montpellier Hôpital Gui de Chauliac
  • University Hospital of Nancy (CHRU) Hôpital central
  • Fondation Adolphe de Rothschild Hospital
  • University Hospital Pitié-Salpétrière AP-HP
  • Foch Hospital Centre
  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Strategy Group

Control Strategy Group

Arm Description

endovascular treatment in addition to best medical treatment

best medical treatment

Outcomes

Primary Outcome Measures

Rate of patients achieving a functional recovery defined by modified Rankin Scale 0-2 at 3 months
Good functional outcome will be defined by a Modified Rankin Scale of 0-2, done by a certified rater, blinded of the arm of the randomization

Secondary Outcome Measures

modified Rankin Scale
Rate of patients with Modified Rankin Scale of 0-2 , rate of patients with Modified Rankin Scale 0-3 and Global disability assessed by overall distribution of the Modified Rankin Scale (shift analysis combining scores 5 and 6)
National Institute of Health Scale
Rate of patients achieving an early neurological improvement National Institutes of Health Stroke Scale (NIHSS) >or=8 reduction from baseline to day 1 or National Institutes of Health Stroke Scale (NIHSS) =0-1 at day 1
Modified Thrombolysis in Cerebral Infarction score
Rate of successful reperfusion in the EndoVascular Treatment+Best medical treatment arm defined by a mTICI ( Modified Thrombolysis in Cerebral Infarction) 2bc3 score
mortality rate
Number of subject who die during the study participation in each arm.
Symptomatic Hemorrhagic Transformation
Symptomatic hemorrhagic transformation is defined by an intra cerebral hemorrhage (European Cooperative Acute Stroke Study III classification " ECASS III ") associated with a 4 or more point increase on the National Institute of Health " NIH " Stroke Scale by comparison with NIH Stroke Scale immediately predeterioration.

Full Information

First Posted
July 11, 2022
Last Updated
June 8, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05539404
Brief Title
Evaluate Endovascular Treatment of Large Ischemic Stroke With Substantial Penumbra.
Acronym
FrameLP
Official Title
French Acute Randomized Controlled Trial Using Multimodal Imaging for Endovascular Treatment of Patients With Large Cerebral Infarction With Substantial Penumbra up to 24 Hours
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Study ends for scientific reasons
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
April 18, 2023 (Actual)
Study Completion Date
April 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

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
Large cerebral infarctions are frequent and associated with a poor outcome. Previous cohort studies results suggest that patients with an acute ischemic stroke with large core and substantial penumbra on perfusion imaging benefit from EVT while those with no salvageable ischemic tissue did not. The Investigator aim to demonstrate in a randomized controlled trials (RCT) that EVT (Endo Vascular Treatment) in addition to BMT (Best Medical Treatment) increases the rate of functional recovery (mRS 0-2) at 3 months in patients with a LVO-related AIS with a large core and substantial penumbra evolving for less than 24hrs
Detailed Description
The reperfusion of salvageable ischemic tissue (penumbra) to improve functional recovery is the aim of the endovascular treatment (EVT) of acute ischemic stroke (AIS) complicating large cerebral vessel occlusion (LVO). Downstream of an LVO, imaging profiles are highly variable ranging from a large completed infarction within 2 hrs to a small core and a large mismatch at 24 hrs after onset . A large core is typically associated with a poor prognosis and was a common exclusion criterion from the RCTs that demonstrated the efficacy of EVT for LVO related AIS . However the investigator recently reported that AIS with a large core 1- represent 20% of the LVO-related AIS scanned within 6 hours after onset 2- Up to 50% had a MM on perfusion imaging and 3- EVT increases the rate of functional recovery in patients with a large core over BMT only in the subgroup of patients with a MM (Mismatch) on baseline imaging . One hundred and eighty patients experiencing an LVO-related AIS within 24 hours after last known well, with a documented large core (>70mL) and a MM on baseline imaging will be randomized (1:1) to undergo EVT+BMT vs. BMT in a multicenter, randomized, controlled, open-label, in parallel groups with blinded endpoint evaluation (PROBE design) superiority trial. Study participants will be followed up for 6 months. Participants will be treated and managed in acute stroke units by certified stroke neurologists and neurointerventionists according to the current recommendations . Neurological deficit will be assessed using the NIH Stroke Scale (NIHSS) by certified investigators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Acute ischemic stroke, large stroke, Multimodal brain imaging, Thrombectomy, endovascular treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Strategy Group
Arm Type
Experimental
Arm Description
endovascular treatment in addition to best medical treatment
Arm Title
Control Strategy Group
Arm Type
No Intervention
Arm Description
best medical treatment
Intervention Type
Procedure
Intervention Name(s)
Endovascular treatment in addition of best medical treatment.
Other Intervention Name(s)
Mechanical thrombectomy
Intervention Description
Endovascular treatment (EVT) of acute ischemic stroke (AIS) related to an anterior large cerebral vessel occlusion (LVO)
Primary Outcome Measure Information:
Title
Rate of patients achieving a functional recovery defined by modified Rankin Scale 0-2 at 3 months
Description
Good functional outcome will be defined by a Modified Rankin Scale of 0-2, done by a certified rater, blinded of the arm of the randomization
Time Frame
3 months
Secondary Outcome Measure Information:
Title
modified Rankin Scale
Description
Rate of patients with Modified Rankin Scale of 0-2 , rate of patients with Modified Rankin Scale 0-3 and Global disability assessed by overall distribution of the Modified Rankin Scale (shift analysis combining scores 5 and 6)
Time Frame
3 and 6 months
Title
National Institute of Health Scale
Description
Rate of patients achieving an early neurological improvement National Institutes of Health Stroke Scale (NIHSS) >or=8 reduction from baseline to day 1 or National Institutes of Health Stroke Scale (NIHSS) =0-1 at day 1
Time Frame
Day 1
Title
Modified Thrombolysis in Cerebral Infarction score
Description
Rate of successful reperfusion in the EndoVascular Treatment+Best medical treatment arm defined by a mTICI ( Modified Thrombolysis in Cerebral Infarction) 2bc3 score
Time Frame
Day 1
Title
mortality rate
Description
Number of subject who die during the study participation in each arm.
Time Frame
3 and 6 months
Title
Symptomatic Hemorrhagic Transformation
Description
Symptomatic hemorrhagic transformation is defined by an intra cerebral hemorrhage (European Cooperative Acute Stroke Study III classification " ECASS III ") associated with a 4 or more point increase on the National Institute of Health " NIH " Stroke Scale by comparison with NIH Stroke Scale immediately predeterioration.
Time Frame
36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients experiencing an acute ischemic stroke related to an anterior proximal large vessel occlusion (ICA/M1/Tandem) on MR or CT-angiography evolving for less than 24 hours from last known to be well. For patients experiencing a wake-up stroke or a stroke of unknown onset the mid-point between last seen well and symptoms discovery + the delay between symptoms discovery to randomization, will be used to calculate the delay between symptom onset to randomization. On baseline imaging (MRI Diffusion Weighted Imaging/Perfusion Weighted Imaging or CTP) L.P. profile defined by a Large Core > 70 mL, and a MM ratio>1.4 using RAPID software. Delay between end of imaging and randomization <90 min. Expected delay between end of imaging and femoral puncture < 60 min Best medical treatment including IV thrombolysis if indicated Surrogate decision maker's consent or emergency inclusion form. Affiliated person or beneficiary of a social security scheme. Exclusion Criteria: Pre-Stroke mRS >1. Other serious advanced or terminal illness or life expectancy is estimated to be less than 6 months. Pre-existing medical, neurological or psychiatric condition that would confound the neurological or functional evaluation. Pregnancy and breastfeeding Inability to undergo contrast brain perfusion MR or CT. Technically inadequate perfusion imaging precluding L.P. profile assessment Occlusion in multiple proximal vascular site territories (eg. bilateral anterior circulation occlusion or anterior + posterior circulation occlusions). Known allergy to iodine precluding EVT. Vessel anatomy or tortuosity precluding EVT. Patient under judicial protection. Participation in another interventional or therapeutic study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc OLIVOT, MD PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
University Hospital of Lille Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
590370
Country
France
Facility Name
University Hospital of Limoges Hôpital Dupuytren 1
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
University Hospital of Montpellier Hôpital Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
University Hospital of Nancy (CHRU) Hôpital central
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Fondation Adolphe de Rothschild Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
University Hospital Pitié-Salpétrière AP-HP
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Foch Hospital Centre
City
Suresnes
ZIP/Postal Code
92150
Country
France
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluate Endovascular Treatment of Large Ischemic Stroke With Substantial Penumbra.

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