Clinical trial NCT00334061: Study to Assess the Safety and Effectiveness of the Penumbra System
Official title: Evaluation of the Penumbra™ Stroke System in the Revascularization of Patients With Acute Ischemic Stroke Secondary to Intracranial Large Vessel Occlusive Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Penumbra
Ischemic
Stroke
Intervention
Neurovascular
Thrombus
Embolectomy
Ischemic stroke
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2006-06-06
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Purpose:

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. Up to 125 evaluable patients will be enrolled in the study.

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 \< 30,000
* Pre-existing neurological or psychiatric disease that could confound the study results
* Known severe allergy to contrast media
* Uncontrolled hypertension
* Computed tomography (CT) evidence of significant mass effect with a midline shift
* CT reveals evidence of large hypodensity region \> 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.

Primary outcomes:
measure: Percentage of Participants With Revascularization of the Occluded Target Vessel
timeFrame: 3-Month Post-Procedure
measure: Percentage of Participants With Device-related and Procedure-related Serious Adverse Events
timeFrame: 3-Month Post-Procedure
Secondary outcomes:
measure: 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
timeFrame: Discharge or 30-Days Post-Procedure
measure: Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment
timeFrame: 90-Day
measure: Percentage of Participants With All Cause Mortality
timeFrame: 90-Days Post-Treatment
measure: Percentage of Participants With Symptomatic Hemorrhage
timeFrame: 24-Hour Post-Procedure
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
Study officials:
References: