Evaluate Endovascular Treatment of Large Ischemic Stroke With Substantial Penumbra.

NCT05539404 | Terminated DMC

• 2 other identifiers: RC31/21/03362021-A03139-32
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 9

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

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke; large stroke; Multimodal brain imaging; Thrombectomy; endovascular treatment

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (5)

• modified Rankin Scale

  3 and 6 months

• National Institute of Health Scale

  Day 1

• Modified Thrombolysis in Cerebral Infarction score

  Day 1

• mortality rate

  3 and 6 months

• Symptomatic Hemorrhagic Transformation

  36 hours

Study Arms (2)

Experimental Strategy Group

EXPERIMENTAL

endovascular treatment in addition to best medical treatment

Procedure: Endovascular treatment in addition of best medical treatment.

Control Strategy Group

NO INTERVENTION

best medical treatment

Interventions

Endovascular treatment in addition of best medical treatment. PROCEDURE

Endovascular treatment (EVT) of acute ischemic stroke (AIS) related to an anterior large cerebral vessel occlusion (LVO)

Also known as: Mechanical thrombectomy

Experimental Strategy Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Affiliated person or beneficiary of a social security scheme.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (9)

Hôpital Pellegrin

Bordeaux, 33076, France

Location

University Hospital of Lille Hôpital Roger Salengro

Lille, 590370, France

Location

University Hospital of Limoges Hôpital Dupuytren 1

Limoges, 87042, France

Location

University Hospital of Montpellier Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

University Hospital of Nancy (CHRU) Hôpital central

Nancy, 54000, France

Location

Fondation Adolphe de Rothschild Hospital

Paris, 75019, France

Location

University Hospital Pitié-Salpétrière AP-HP

Paris, 75651, France

Location

Foch Hospital Centre

Suresnes, 92150, France

Location

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean-Marc OLIVOT, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: September 14, 2022
• Study Start: November 2, 2022
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)