Penumbra Imaging Collaborative Study (PICS)

Stroke Clinical Trial

— PICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785161
• Other study ID #: CLP 1953.A
• Status: Completed
• First received: November 3, 2008
• Last updated: April 10, 2018
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2018
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Penumbra System
Mechanical Thrombectomy in acute stroke

Locations

Country	Name	City	State
United States	Swedish Medical Center	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System.		Admission
Primary	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
Primary	The proportion of patients with a modified Rankin Score (mRS) of =2 at 90 days post-procedure.		90-Days Post-Procedure
Secondary	Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge.		Admission and Discharge
Secondary	Incidence of intracranial hemorrhage.		24-Hours Post-Procedure
Secondary	Incidence of device-related serious adverse events.		During the Procedure
Secondary	All cause mortality at 90 days post-procedure.		90-Days Post-Procedure

External Links

•   Penumbra Website