Study to Assess the Safety and Effectiveness of the Penumbra System

NCT00334061 | Completed Phase 2 Results DMC

• 1 other identifier: CLP 0676
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Penumbra; Ischemic; Stroke; Intervention; Neurovascular; Thrombus; Embolectomy; Ischemic stroke

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Revascularization of the Occluded Target Vessel

  Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.

  3-Month Post-Procedure

• Percentage of Participants With Device-related and Procedure-related Serious Adverse Events

  3-Month Post-Procedure

Secondary Outcomes (4)

• 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

  Discharge or 30-Days Post-Procedure

• Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment

  90-Day

• Percentage of Participants With All Cause Mortality

  90-Days Post-Treatment

• Percentage of Participants With Symptomatic Hemorrhage

  24-Hour Post-Procedure

Interventions

Penumbra System DEVICE

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical signs consistent with acute ischemic stroke
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (1)

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stroke; Ischemia; Thrombosis; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Results Point of Contact

• Title: Siu Po Sit, PhD Study Coordinator
• Organization: Penumbra Inc

siupo.sit@penumbrainc.com

510 748 3200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2006
• First Posted: June 6, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: November 1, 2007
• Last Updated: September 18, 2019
• Results First Posted: January 12, 2009

Record last verified: 2019-09

Locations

US (1)