The randomized, open label, active control, parallel assignment, safety/efficacy study is currently recruiting subjects in US with the estimation enrollment of 250. The study chair will be Daryl R. Gress, M.D. From University of Virginia (Chair – VISSIT Data Safety Monitoring Board).
PHAROS Vitesse intracranial balloon-expandable stent is used to treat ischemic disease and for scaffolding of wide-neck aneurysms to ensure that the microcoil is not dislodged. The stent will dilate intracranial arteries that have narrowed and allows to deliver and deploy a stent in one step eliminating the need for pre-dilation of constricted vasculature. PHAROS Vitesse features a new distal tip that is longer and softer, a newly designed, thinner balloon and company’s rapid exchange delivery system. It incorporates a coating which may reduce the need for retreatment due to restenosis.