The Penumbra Pivotal Stroke Trial

In this prospective, multicenter, single-arm study, 125 patients with neurological deficits as defined by a National Institutes of Health Stroke Scale score > or =8, presented within 8 hours of symptom onset, and an angiographic occlusion (Thrombolysis In Myocardial Infarction [TIMI] Grade 0 or 1) of a treatable large intracranial vessel were enrolled. Patients who presented within 3 hours from symptom onset had to be ineligible or refractory to recombinant tissue plasminogen activator therapy. All patients were followed clinically for 90 days postprocedure.

A total of 125 target vessels in 125 patients were treated by the Penumbra System. Postprocedure, 81.6% of the treated vessels were successfully revascularized to TIMI 2 to 3. There were 18 procedural events reported in 16 patients (12.8%), 3 patients (2.4%) had events that were considered serious. A total of 35 patients (28%) were found to have intracranial hemorrhage on 24-hour CT of which 14 (11.2%) were symptomatic. All cause mortality was 32.8% at 90 days with 25% of the patients achieving a modified Rankin Scale score of