Selection

Inclusion criteria

  • Patient has a pre-procedure modified Rankin Score 0, 1, 2, or 3.
  • Patient is at least 18 years old on the date he/she signed the informed consent and the signing of the informed consent is no more than 30 days before the pre-op examination and inclusion.
  • Patient requires a temporary or permanent bypass to be connected to one or more unoccluded intracranial vessel(s) for an established indication and cannot be safely treated otherwise e.g., because of a lesion not ideal for coiling or clipping or excision or temporary or permanent occlusion of a vessel without the temporary or permanent creation of a bypass. 
  • From preoperative considerations it seems that the patient can provide a segment of saphenous vein (VSM) to serve as the donor graft, which does not seem to be varicose, obliterated or stenosed and which can be expected to have a diameter compatible with the proximal and distal target vessels and sufficient length to bridge the distance from the proximal to the distal anastomosis.
  • For women in child-bearing age: pregnancy test with negative result and use of birth control confirmed.

Preoperative Exclusion criteria:

  • Patient is pregnant or cannot take birth control.
  • Patient cannot be without clopidogrel (Plavix®) for the surgery and through discharge.
  • Patient has a life expectancy of less than 30 days.
  • Patient participates in another clinical investigation that could confound the evaluation of the Study device.
  • Patient is allergic to Asperin.
  • Surgeon believes the patient is an unsuitable surgical candidate because of a poor general state of health, which would not permit the required operating and anesthesia time (add at an appropriate safety margin - at least 50% - to the expected surgery time in the assessment) or because of abnormal blood.