Penumbra Imaging Collaborative Study (PICS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT00785161
First received: November 3, 2008
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The primary aim of this study are to gather data on the "real world" experience of the Penumbra System and to determine if there is a correlate between the imaging-defined size of the ischemic penumbra at admission and patient outcome in patients already treated by the System. This will be accomplished by the collection of all available admission imaging data along with patient clinical and functional outcome results at 90-day follow-up to determine if a positive association exists between these variables. A secondary aim is to collect and summarize the 90-day functional outcome data for the purpose of sample size estimation for a potential randomized concurrent controlled trial. This will be accomplished by collecting the data on 90-day modified Rankin Scores (mRS) and all cause mortality.


Condition Intervention Phase
Stroke
Device: Penumbra System
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System

Resource links provided by NLM:


Further study details as provided by Penumbra Inc.:

Primary Outcome Measures:
  • Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System. [ Time Frame: Admission ] [ Designated as safety issue: No ]
  • Proportion of patients with successful revascularization of the occluded target vessel as defined by a TIMI score of 2 or 3 following use of the Penumbra System. [ Time Frame: Post-Procedure ] [ Designated as safety issue: No ]
  • The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure. [ Time Frame: 90-Days Post-Procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge. [ Time Frame: Admission and Discharge ] [ Designated as safety issue: No ]
  • Incidence of intracranial hemorrhage. [ Time Frame: 24-Hours Post-Procedure ] [ Designated as safety issue: No ]
  • Incidence of device-related serious adverse events. [ Time Frame: During the Procedure ] [ Designated as safety issue: No ]
  • All cause mortality at 90 days post-procedure. [ Time Frame: 90-Days Post-Procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: August 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Penumbra System
    Mechanical Thrombectomy in acute stroke
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A stroke cohort who were revacularized by the Penumbra System

Criteria

Inclusion Criteria:

  • All patients who signed informed consent and revascularized by the Penumbra™ System in accordance to the Instruction For Use are eligible for this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785161

Locations
United States, Colorado
Swedish Medical Center
Englewood, Colorado, United States, 80113
Sponsors and Collaborators
Penumbra Inc.
Investigators
Study Director: Siu Po Sit, PhD Penumbra Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT00785161     History of Changes
Other Study ID Numbers: CLP 1953.A
Study First Received: November 3, 2008
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Penumbra Inc.:
Penumbra System
Mechanical Thrombectomy
Ischemic Stroke
Intervention
Neurovascular
Thrombus
Imaging
Ischemic Penumbra
Functional Outcome

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

ClinicalTrials.gov processed this record on April 17, 2014