StrokePICSNCT00785161
Penumbra Imaging Collaborative Study (PICS)
An observational study of Stroke, run by Penumbra Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Penumbra System
- Type of treatment
- Medical device
- How many people
- 289 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A stroke cohort who were revacularized by the Penumbra System
Who may be able to join
- All patients who signed informed consent and revascularized by the Penumbra™ System in accordance to the Instruction For Use are eligible for this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System
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
- Being tested
- Penumbra System
- Keywords
- Penumbra System, Mechanical Thrombectomy, Ischemic Stroke, Intervention, Neurovascular, Thrombus, Imaging, Ischemic Penumbra, Functional Outcome
- Medical subject headings
- Stroke, Ischemic Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penumbra SystemDevice
Mechanical Thrombectomy in acute stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System.
Measured: 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.
Measured: Post-Procedure
The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure.
Measured: 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.
Measured: Admission and Discharge
Incidence of intracranial hemorrhage.
Measured: 24-Hours Post-Procedure
Incidence of device-related serious adverse events.
Measured: During the Procedure
All cause mortality at 90 days post-procedure.
Measured: 90-Days Post-Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siu Po Sit, PhD, Study director, Penumbra Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785161
- Sponsor's protocol ID
- CLP 1953.A
- Acronym
- PICS
- Status last verified
- Apr 2018
- First submitted
- 3 Nov 2008
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penumbra Imaging Collaborative Study (PICS): A Multicenter Trial to Assess Outcome of Patients Revascularized by the Penumbra™ System
- ClinicalTrials.gov ID
- NCT00785161
- Acronym / sponsor ID
- PICS / CLP 1953.A
- Conditions
- Stroke
- Keywords
- Penumbra System, Mechanical Thrombectomy, Ischemic Stroke, Intervention, Neurovascular, Thrombus, Imaging, Ischemic Penumbra
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A stroke cohort who were revacularized by the Penumbra System
Key inclusion criteria (1 listed)
- All patients who signed informed consent and revascularized by the Penumbra™ System in accordance to the Instruction For Use are eligible for this study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penumbra SystemMechanical Thrombectomy in acute stroke | Device | – |
Primary outcome
Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System.
Time frame: 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.
Time frame: Post-Procedure
The proportion of patients with a modified Rankin Score (mRS) of ≤2 at 90 days post-procedure.
Time frame: 90-Days Post-Procedure
4 secondary outcomes
Neurological status as defined by the National Institute of Health Stroke Scale (NIHSS) scores at Admission and Discharge.
Time frame: Admission and Discharge
Incidence of intracranial hemorrhage.
Time frame: 24-Hours Post-Procedure
Incidence of device-related serious adverse events.
Time frame: During the Procedure
All cause mortality at 90 days post-procedure.
Time frame: 90-Days Post-Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Penumbra WebsiteLink provided by the sponsor.
Related trials for Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siu Po Sit, PhD study director
Penumbra Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Penumbra Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with an imaging-defined ischemic penumbra at admission that warrants revascularization by the Penumbra System. (time frame: Admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.