An Open, Study to Assess the Safety of RGTA® (OTR4132) in Patients With Acute Ischemic Stroke (AIS) (MATRISS)

This is an interventional treatment trial for Stroke, Acute focused on measuring Stroke, FIM, OTR3 Read More

Inclusion Criteria:

• Eligible patients for this study will be included if all of the following conditions are met:

  1. Age 18 to 80 years
  2. Acute ischemic stroke in anterior circulation territory, identified by magnetic resonance imaging (MRI)
  3. Occlusion of anterior circulation i.e. internal carotid artery or proximal middle cerebral artery (MCA) (M1, M1/M2)
  4. Volume of the lesion estimated below two third of the MCA territory
  5. Intravenous (IV) thrombolysis performed according to European Stroke Organization (ESO) guidelines
  6. Intravenous Alteplase (1h infusion) terminated at least 40min before effective thrombectomy; or Intravenous Tenecteplase (bolus) terminated at least 120min before effective thrombectomy
  7. Endovascular thrombectomy initiated within 6 hours of stroke onset
  8. Angiography after endovascular treatment: TICI grade 2b - 3
  9. Baseline NIHSS (National Institute of Health Stroke Score), including hand testing 11 and 25 at screening
  10. No significant pre-stroke disability (pre-baseline modified Rankin Score (mRS) 0-1)
  11. Able to follow neuro-rehabilitation programme

  12. Patient* or legally authorized representative (family member, trusted person or physician) if patient unable to give consent has signed informed consent.

      • Patients unable to give consent at baseline will go through a deferred consent procedure to continue the study (Section 12: Subject Information and Informed Consent)

Exclusion Criteria:

• Eligible patients for this study will not be included if any of the following conditions are present:

  1. Previous symptomatic stroke
  2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological evaluation
  3. Contra-indication to MRI
  4. Evidence of intracranial haemorrhage (ICH)
  5. At the discretion of the investigator, patients with co-morbidities associated with a 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
  6. History of allergy or anaphylactic reactions to any of the ingredients of OTR4132-MD or heparinoids
  7. Severe renal failure with glomerular filtration rate (GFR) < 30 mL/min
  8. 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
  9. Increased risk of haemorrhage (such as medical history of significant bleeding disorders, major surgery or significant trauma in the past 3 months, any history of central nervous damage or suspected intracranial haemorrhage, symptoms suggestive of subarachnoid haemorrhage, even if the MRI is normal, international normalized ratio (INR)>1.3 or activated partial thromboplastin time (aPTT)>ULN (upper limit of normal)
  10. Suspected cerebral vasculitis based on medical history and imaging
  11. Occlusions in multiple vascular territories
  12. Evidence of intracranial tumour
  13. Evidence of any prior intracranial intervention (i.e. neurosurgery, endovascular intervention)
  14. Worsening of medical or neurological conditions or per-procedures complications
  15. Any other serious, advanced, or terminal illness (investigator judgment)
  16. Pregnant or breastfeeding or women without an adequate contraceptive method
  17. Current participation in another investigation drug or device study
  18. The patient is not a member or beneficiary of a social security scheme