The Penumbra Stroke Trial

Safety and Effectiveness of a New Generation of Mechanical Devices for Clot Removal in Acute Ischemic Stroke. 

Trial Design

• Prospective, single arm, multi-center trial
• Enrolled 125 patients at 24 international centers
• Patients in the trial presented within 8 hours from symptom onset, had an NIH Stroke Scale (NIHSS) score of ≥ 8, and had a complete occlusion of a large intracranial vessel
  
  

Primary Endpoints

• Revascularization of the occluded vessel
• Procedure and device-related serious adverse events
• Primary endpoints, as well as their comparative historical controls were prospectively defined and agreed upon with FDA prior to the start of the trial
  
  

Primary Endpoint Results

• 81.6% rate of revascularization (TIMI score 2 or 3) of the occluded vessel verses the 48.2% historical control¹ (p < 0.0001)
• 3.2% procedural serious adverse events (SAE) rate verses the 7.1% historical control¹
• There were no device-related SAEs
• No SAEs were attributed to device malfunction or breakage
• All angiographic and clinical results were adjudicated and reviewed by an independent core laboratory, clinical events committee and safety monitoring board.
  
  

Secondary Endpoints & Results

• Symptomatic intracerebral hemorrhage in 14 out of 125 (11.2%) patients
• Asymptomatic intracerebral hemorrhage in 21 out of 125 (16.8%) patients
• ≥ 4 point improvement in NIHSS at discharge achieved by 57.8% of patients
• modified Rankin Score (mRS) < 2 at 90 days achieved by 25% of patients
• All cause mortality of 26.4% and 32.8% at 30 and 90 days respectively
• The clinical and functional outcomes in this 125 patient cohort are in the range of previously published data on treatment outcomes in acute stroke
• Penumbra is currently considering clinical trials with a randomized, concurrent control arm that would generate relevant data about the treatment effect of the Penumbra System on such clinical and functional endpoints.
  
  

The Effect of Revascularization

• The 103 patients out of 125 (81.6%) whose intracranial vessels were opened by the Penumbra System had better results than the patients not revascularized across every measure of clinical and functional outcome including
  • modified Rankin Score < 2 at 90 days
  • ≥4 point improvement in NIHSS at discharge
  • 30 and 90 day mortality
• This finding confirms results from previously published studies that consistently demonstrate better outcomes for patients whose vessels are opened following a stroke, rather than remaining closed.

The abstract of the Penumbra System Trial was presented at the 2008 International Stroke Conference in New Orleans, LA.


¹ Smith, et. al., Stroke 2005;36:1432