Micrus Endovascular Corporation (Micrus), is planning to complete the trial entitled “Phase III Study of Pharos Vitesse Neurovascular Stent System Compared to Best Medical Therapy for the Treatment of Ischemic Disease” for PHAROS Vitesse stent by June 2011. The study primary objective is to prospectively evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse Neurovascular Stent System in a multicenter, randomized clinical trial. The study secondary objective is to evaluate the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes such as hospital length of stay, charges, and costs.
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.