A Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients With Acute Ischemic Stroke

Korábbi kezelés

• Previous symptomatic stroke with permanent sequelae
• Evidence of any prior intracranial intervention (i.e. neurosurgery, endovascular intervention)
• Current participation in another therapeutic investigation (drug or device)

Más betegség

• Pre-existing medical, neurological, or psychiatric disease that would confound the neurological evaluation
• Stroke lesion not visible on MRI
• History of allergy or anaphylactic reactions to any of the ingredients of OTR4132-MD or heparinoids
• History of hypersensitivity or anaphylactic reactions to iodinated contrast media
• Severe uncontrolled arterial hypertension e.g. systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, or intravenous medication necessary to reduce blood pressure
• Life expectancy of less than 3 months or co-morbidities that could influence the study results or would complicate assessment of outcomes (e.g. dementia, psychiatric disease) or would make clinical follow-up difficult
• Worsening of medical or neurological conditions or per-procedures complications
• Any other serious, advanced, or terminal illness (investigator judgment)

Laborértékek

• Severe renal failure with glomerular filtration rate (GFR) < 30 mL/min
• Increased risk of hemorrhage (for instance medical history of significant bleeding disorders, major surgery or significant trauma in the past 3 months, any history of suspected intracranial hemorrhage, symptoms suggestive of subarachnoid hemorrhage, even if the MRI is normal, international normalized ratio (INR)>1.3 or activated partial thromboplastin time (aPTT)>ULN (upper limit of normal)

Egyéb

• Contraindication to MRI
• Intracranial tumor at inclusion
• Pregnant or breastfeeding women
• Suspected cerebral vasculitis based on medical history and imaging
• Occlusions in multiple vascular territories
• The patient is not a member or beneficiary of the French social security system

• Age between 18 and 85 years
• Acute ischemic stroke in anterior circulation territory, identified by magnetic resonance imaging (MRI).
• Occlusion of anterior circulation i.e. carotid artery (ICA) or proximal middle cerebral artery (MCA) (M1 and/or M2 segment)
• Endovascular thrombectomy (with or without previous intravenous thrombolysis)
• Recanalization confirmed by angiography after endovascular treatment: TICI grade 2b - 3
• NIHSS (National Institute of Health Stroke Scale/Score) ≥ 11
• Pre-stroke modified Rankin Score (mRS): 0 or 1
• Patient* or legally authorized representative (family member or trusted person if patient unable to give consent) or independent physician (if patient unable to give consent and if an authorized representative cannot be reached) has signed informed consent.
  • Patients unable to give consent at baseline will go through a deferred consent procedure to continue the study