Status:
UNKNOWN
Minor Stroke Therapy Evaluation
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Stroke
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Stroke represents the fourth leading cause of death in industrialized nations, after heart disease, cancer, and chronic lower respiratory disease. Approximately one-quarter of the patients suffering a...
Detailed Description
Proximal intracranial arterial occlusions cause the most disabling types of ischemic strokes and are predictive of poor neurological outcomes. The "Time is Brain" assessment has been confirmed in many...
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years old at inclusion (no upper age limit)
- Clinical signs consistent with acute ischemic stroke with time last known well (TLKW) ≤ 23h at randomization (With the goal of remaining within 24 hours from TLKW til treatment)
- Patients NIHSS 0-5 at the time of randomization
- ASPECT ≥ 6 on non-contrast CT or Diffusion Weighted Imaging (DWI)-MRI
- Ischemic Stroke confirmed with cerebral imaging or normal imaging with suspected ischemic stroke
- Proved anterior circulation intracranial large vessel occlusion on CTA or Magnetic resonance angiography (MRA) (ICA, M1, M1-M2, with or without cervical lesion (Tandem))
- Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent Form, or fulfilling the criteria for emergent consent.
- Anticipated possibility to start the procedure (arterial access) within 60 minutes after randomization
- Pre stroke mRS ≤ 1
- For Drip and Ship patients : new imaging performed again on inclusion center if first imaging performed \> 1 hour before randomization.
Exclusion
- General Exclusion Criteria
- Anticipated impossibility to start the procedure (arterial access) within 60 minutes after randomization
- Known absence of vascular access
- Known contrast or endovascular product life-threatening allergy
- Female who is known to be pregnant or lactating at time of admission
- Patient presents severe or fatal co-morbidities or Life expectancy under 6 months that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
- Patient unable to present or be available for follow-up
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
- Evidence of vessel recanalization prior to randomization
- Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
- Current participation in another investigational drug study
- Suspicion of aortic dissection based on medical history, clinical evaluation or/and imaging
- Major patients under guardianship
- Imaging Exclusion Criteria
- Evidence of intracranial hemorrhage on CT/MRI
- Excessive tortuosity of cervical vessels on CTA/MRA that would likely result in unstable access platform
- High Suspicion of underlying intracranial stenosis on CTA/MRA
- Suspected cerebral vascular disease (e.g. vasculitis) based on medical history and CTA/MRA
- Presumed calcified Embolus or Intracranial Stenosis decompensation
- Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the stentriever device
- Occlusions in multiple vascular territories (e.g.: bilateral anterior circulation, or anterior circulation/vertebrobasilar system) on CTA/MRA
- Significant mass effect with midline shift as confirmed on CT/MRI
Key Trial Info
Start Date :
April 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
824 Patients enrolled
Trial Details
Trial ID
NCT03796468
Start Date
April 10 2019
End Date
October 1 2025
Last Update
August 31 2023
Active Locations (1)
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1
Hopital Gui De Chauliac
Montpellier, France, 34295