Penumbra Imaging Collaborative Study (PICS)

NCT00785161 | Completed

• 1 other identifier: CLP 1953.A
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Penumbra System; Mechanical Thrombectomy; Ischemic Stroke; Intervention; Neurovascular; Thrombus; Imaging; Ischemic Penumbra; Functional Outcome

Outcome Measures

Primary Outcomes (3)

• Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System.

  Admission

• 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.

  Post-Procedure

• The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure.

  90-Days Post-Procedure

Secondary Outcomes (4)

• Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge.

  Admission and Discharge

• Incidence of intracranial hemorrhage.

  24-Hours Post-Procedure

• Incidence of device-related serious adverse events.

  During the Procedure

• All cause mortality at 90 days post-procedure.

  90-Days Post-Procedure

Interventions

Penumbra System DEVICE

Mechanical Thrombectomy in acute stroke

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A stroke cohort who were revacularized by the Penumbra System

You may qualify if:

• All patients who signed informed consent and revascularized by the Penumbra™ System in accordance to the Instruction For Use are eligible for this study.

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (1)

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Related Links

• Penumbra Website

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Thrombosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Siu Po Sit, PhD

  Penumbra Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 5, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

US (1)