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Penumbra Imaging Collaborative Study (PICS) (PICS)

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ClinicalTrials.gov Identifier: NCT00785161
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Brief Summary:
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 or disease Intervention/treatment
Stroke Device: Penumbra System

Study Type : Observational
Actual Enrollment : 289 participants
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
Actual Study Start Date : October 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Device: Penumbra System
    Mechanical Thrombectomy in acute stroke


Primary Outcome Measures :
  1. Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System. [ Time Frame: Admission ]
  2. 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 ]
  3. The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure. [ Time Frame: 90-Days Post-Procedure ]

Secondary Outcome Measures :
  1. Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge. [ Time Frame: Admission and Discharge ]
  2. Incidence of intracranial hemorrhage. [ Time Frame: 24-Hours Post-Procedure ]
  3. Incidence of device-related serious adverse events. [ Time Frame: During the Procedure ]
  4. All cause mortality at 90 days post-procedure. [ Time Frame: 90-Days Post-Procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Additional Information:
Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT00785161     History of Changes
Other Study ID Numbers: CLP 1953.A
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

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