Study to Assess the Safety and Effectiveness of the Penumbra System
This study has been completed.
Sponsor:
Penumbra Inc.
Information provided by:
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT00334061
First received: June 2, 2006
Last updated: January 9, 2009
Last verified: December 2008
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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) |
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 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 May 19, 2013