Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke (SOLONDA)

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Thrombectomy Read More

Inclusion Criteria:

• Clinical

  1. Age ≥18 and ≤85 years.
  2. Informed consent obtained from subject or acceptable subject surrogate (i.e. next of kin, or legal representative).
  3. A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
  4. Baseline NIHSS obtained prior to procedure ≥ 8 points and ≤ 25 points.
  5. Pre-ictal mRS score of 0 or 1.
  6. Treatable as soon as possible and at least within 8 h of symptom onset, defined as point in time when the subject was last seen well (at baseline). (Treatment start is defined as groin puncture.)
  7. Subjects for whom intravenous (IV) tissue plasminogen activator (t PA) is indicated and who are available for treatment, are treated with IV t-PA. For such patients, IV t-PA should be administered as recommended by the American Heart Association/American Stroke Association (AHA/ASA) Guidelines for the early management of patients with AIS.

  8. IV t-PA, if used, is initiated as soon as possible and within 3 h of stroke onset (onset time is defined as the last time when the patient was witnessed to be well at baseline), with investigator verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight.

     Neuro Imaging

  9. Occlusion (TICI 0 or TICI 1 flow), of the terminal internal carotid artery, M1 or M2 segments of the middle cerebral artery, suitable for mechanical embolectomy, confirmed on conventional angiography.

  10. The following imaging criteria should also be met:

      1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL. OR
      2. CT criterion: Alberta Stroke program early CT score (ASPECTS) 6 to 10 on baseline CT or CT-Angiography (CTA)-source images, or, volume of significantly lowered Cerebral Blood Volume (CBV) ≤50 mL.
  11. The subject is indicated for neurothrombectomy treatment by the Interventionalist.

Exclusion Criteria:

• Clinical

  1. Pre-stroke functional disability (mRS score >1).
  2. Initially treated with a different thrombectomy device.
  3. Subject has suffered a stroke in the past 1 year.
  4. Occlusion (TICI 0 or TICI 1 flow) of the basilar or vertebral arteries
  5. The subject presents with an NIHSS score <8 or >25.
  6. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
  7. Severe arterial tortuosities avoiding stable positioning of the guide catheter in the petrous segment (C2) of Internal Carotid Artery (ICA)
  8. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR >3.0.
  9. Baseline platelet count <50,000/µL.
  10. Baseline blood glucose of <50 mg/dL or >400 mg/dL.

  11. Severe, sustained hypertension (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg).

      NOTE: If the blood pressure can be successfully reduced and maintained at an acceptable level using European Stroke Organisation (ESO) guidelines recommended medication (including IV antihypertensive drips), the patient can be enrolled.

  12. Serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
  13. Subjects with identifiable intracranial tumors.
  14. History of life-threatening allergy (more than rash) to contrast medium.
  15. Known nickel allergy at time of treatment.
  16. Known renal insufficiency with creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30 mL/min.
  17. Cerebral vasculitis.
  18. Evidence of active systemic infection.
  19. Known current use of cocaine at time of treatment.
  20. Woman of childbearing potential who is known to be pregnant, and/or lactating, or who has a positive pregnancy test on admission.
  21. Patient participating in a study involving an investigational drug or device that would impact this study.

  22. Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas).

      Neuro Imaging

  23. Hypodensity on CT or restricted diffusion amounting to an Alberta Stroke Program Early CT (ASPECTS) score of <6 on CT or <5 on diffusion weighted (DW) MRI.
  24. CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
  25. Angiographic evidence of carotid dissection, high grade stenosis or vasculitis.
  26. Significant mass effect with midline shift.
  27. Evidence of complete occlusion, high grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery.
  28. Subjects with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
  29. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
  30. Evidence of intracranial tumor.
  31. Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis.