Study to Assess the Safety and Effectiveness of the Penumbra System

This study has been completed.
Sponsor:
Information provided by:
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT00334061
First received: June 2, 2006
Last updated: January 9, 2009
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Stroke
Device: Penumbra System
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Penumbra™ Stroke System in the Revascularization of Patients With Acute Ischemic Stroke Secondary to Intracranial Large Vessel Occlusive Disease

Resource links provided by NLM:


Further study details as provided by Penumbra Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Revascularization of the Occluded Target Vessel [ Time Frame: 6-Month Post-Procedure ] [ Designated as safety issue: No ]
  • Percentage of Participants With Device-Related and Procedure-Related Serious Adverse Events [ Time Frame: 6-Month Post-Procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Discharge or 30-Days Post-Procedure ] [ Designated as safety issue: No ]
  • Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment [ Time Frame: 90-Day ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With All Cause Mortality [ Time Frame: 90-Days Post-Treatment ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Symptomatic Hemorrhage [ Time Frame: 24-Hour Post-Procedure ] [ Designated as safety issue: Yes ]

Enrollment: 125
Study Start Date: June 2006
Study Completion Date: November 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334061

Locations
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Penumbra Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00334061     History of Changes
Other Study ID Numbers: CLP 0676
Study First Received: June 2, 2006
Results First Received: November 20, 2008
Last Updated: January 9, 2009
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Penumbra Inc.:
Penumbra
Ischemic
Stroke
Intervention
Neurovascular
Thrombus
Embolectomy
Ischemic stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 20, 2014