Cerebrovascular Program Clinical Trials

A Phase IV Trial Assessing the Penumbra System in the Treatment of Acute Stroke (THERAPY): To assess the safety and effectiveness of the Penumbra System as adjunctive treatment to IV rtPA in patients with acute ischemic stroke from large vessel occlusion in the anterior circulation.

A Phase II/III Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke: This is a prospective, randomized, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (>3mm in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D.

A Phase 1/2a Safety and Tolerability Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage (NEWTON): This is a Phase 1/2a multicenter, controlled, open label, and randomized, study. Part 1 of the study is a single dose escalation period to determine the MTD of EG-1962. Upon completion of the dose escalation period, a safe and tolerable dose will be selected for further study. Part 2 of the study is a treatment period to assess the safety and tolerability of the selected dose of EG-1962. The safety and tolerability of a single intraventricular dose of EG 1962 will be compared to enteral nimodipine (60 mg given every 4 hours orally or via nasogastric or gastrostomy tube) for 21 days.

EffectiveNess and SAfety of Small ANeurysm COiling Trial (NANO): To compare the safety and efficacy of treating small aneurysms with coils specially designed for small aneurysms to historically reported rates of safety and efficacy for the treatment of larger aneurysms.

Cerebrovascular Humanitarian Device Exemption (HDE) program

WingspanStent/Gateway Balloon: Device manufacturer: Boston Scientific SMART

Codman/Enterprise Device & Delivery System: Device manufacturer: Codman & Shurtleff, Inc.

Onyx Liquid Embolic System: Device manufacturer: EV3

Neuroform EZ Stent/Microdelivery System: Device manufacturer: Stryker Corp.

LVIS: Device manufacturer: Microvention Inc.