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Completed

NCT Number: NCT00785161

Penumbra Imaging Collaborative Study (PICS)

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Ischemic Stroke Nervous System Diseases Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Penumbra System

Device

Mechanical Thrombectomy in acute stroke

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Official study title

Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System

Acronym: PICS

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 5, 2008
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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