Phase 2
N=125
Study to Assess the Safety and Effectiveness of the Penumbra System
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00334061 ↗Enrolled (actual)
125
Serious AEs
52.0%
Results posted
Jan 2009
Primary outcome: Primary: Percentage of Participants With Revascularization of the Occluded Target Vessel — 81.2 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Penumbra System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Penumbra Inc.
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Revascularization of the Occluded Target Vessel |
81.2 | — |
| PRIMARY Percentage of Participants With Device-related and Procedure-related Serious Adverse Events |
2.4 | — |
| SECONDARY Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment |
41.6 | — |
| SECONDARY Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment |
25 | — |
| SECONDARY Percentage of Participants With All Cause Mortality |
32.8 | — |
| SECONDARY Percentage of Participants With Symptomatic Hemorrhage |
11.2 | — |
Summary
This clinical evaluation is a prospective, single-arm, multi-center trial.
The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.
Eligibility Criteria
Inclusion Criteria
- Clinical signs consistent with acute ischemic stroke
- 18 to 79 years of age
- Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score > 8
- TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System
- Signed informed consent
- Present within 8 hours of stroke symptom onset; ineligible or refractory to intravenous tissue plasminogen activator (t-PA) therapy if presenting within 3 hours of symptom onset.
Exclusion Criteria
- Evidence of rapidly improving neurological signs of stroke at time of enrollment
- NIHSS > 30 or coma
- Females who are pregnant
- Vessel tortuosity too difficult to allow endovascular access
- Known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an International Normalized Ratio (INR) > 3.0
- Partial thromboplastin time (PTT) greater than 2 times the lab normal
- Admission platelets 1/3 of the middle cerebral artery territory
- CT reveals evidence of intracranial hemorrhage
- CT reveals significant mass effect with midline shift
- Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal
- Angiographic evidence of preexisting arterial injury
- Life expectancy of less than 90 days
- Participation in another clinical investigation that could confound the evaluation of the study device.
Data sourced from ClinicalTrials.gov (NCT00334061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.