Last updated on October 2020

Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy (RECOVER)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Large Vessel Occlusion | Cerebrovascular disease | Acute Ischemic Stroke
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Age 18 years.
  2. Symptoms and signs in accordance with anterior circulation ischemia and large vessel occlusion (ICA, MCA-M1 or M2) confirmed by CTA/MRA/DSA.
  3. Pre-stroke Modified Rankin ScalemRS0-1.
  4. NIHSS score 6 points at time of randomization.
  5. The patients should receive endovascular treatment within 8 hours of estimated time of large vessel occlusion (LVO) onset, and have an ASPECTS 6 points on non-enhanced CT.
  6. If intravenous thrombolysis with tPA (IVT) is considered as part of standard medical management, IVT should be started within 4.5 hours of estimated time of LVO. Furthermore, in AIS patients with an unknown time of onset, IVT guided by a mismatch between DWI and FLAIR in the region of ischemia is also recommended.
  7. Written informed consent obtained from patient or patient's legally authorized representative.

Exclusion Criteria:

  1. Acute posterior circulation cerebral infarction comfirmed by CT or MRI.
  2. Any type of cerebral hemorrhage (only microbleeds are allowed) on neuroimaging.
  3. Large (more than one-third of the MCA) regions of clear hypodensity on the baseline CT scan or ASPECTS < 7 points or significant mass effect with midline shift.
  4. Proven occlusion of the common carotid artery.
  5. Known or suspected chronic occlusion of target vessel.
  6. Known life threatening allergy (more than rash) to iodinated contrast agent.
  7. Arterial tortuosity and other problems that would prevent the device from reaching the target vessel.
  8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency.
  9. Baseline platelet count 50000/L.
  10. Severe heart, liver or kidney failure and other serious or terminal illness.
  11. Major surgery within the past 2 weeks
  12. Haemorrhage of the gastrointestinal or urinary tract within the past 3 weeks.
  13. Baseline blood glucose < 2.7 or > 22.2 mmol/L.
  14. Baseline blood pressure > 185/110 mmHg, or aggressive treatment (intravenous medication) necessary to reduce blood pressure to these limits
  15. Pregnant or lactating or positive pregnancy test on admission.
  16. Dementia or psychiatric disease that would confound the neurological or functional evaluations.
  17. Life expectancy less than 1 year.
  18. Current participation in another drug or device research.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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