StrokePhase 2NCT00334061

Study to Assess the Safety and Effectiveness of the Penumbra System

A Phase 2 study testing Penumbra System in people with Stroke, run by Penumbra Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This clinical evaluation is a prospective, single-arm, multi-center trial. The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Stroke
What is being tested?: Penumbra System
Type of treatment: Medical device
How many people: 125 participants
Where: 1 siteUnited States
Study dates: Jun 2006to Nov 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical signs consistent with acute ischemic stroke
18 to 79 years of age
Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score > 8
TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System
Signed informed consent
Present within 8 hours of stroke symptom onset; ineligible or refractory to intravenous tissue plasminogen activator (t-PA) therapy if presenting within 3 hours of symptom onset.

Who cannot join

Evidence of rapidly improving neurological signs of stroke at time of enrollment
NIHSS > 30 or coma
Females who are pregnant
Vessel tortuosity too difficult to allow endovascular access
Known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an International Normalized Ratio (INR) > 3.0
Partial thromboplastin time (PTT) greater than 2 times the lab normal

Show all 18Show fewer

Admission platelets < 30,000
Pre-existing neurological or psychiatric disease that could confound the study results
Known severe allergy to contrast media
Uncontrolled hypertension
Computed tomography (CT) evidence of significant mass effect with a midline shift
CT reveals evidence of large hypodensity region > 1/3 of the middle cerebral artery territory
CT reveals evidence of intracranial hemorrhage
CT reveals significant mass effect with midline shift
Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal
Angiographic evidence of preexisting arterial injury
Life expectancy of less than 90 days
Participation in another clinical investigation that could confound the evaluation of the study device.

Trial locations and contacts

1 site in 1 country.

United States1 site

Saint Luke's Hospital
Kansas City, Missouri, 64111

Other trials in United States

About this study

Official title: Evaluation of the Penumbra™ Stroke System in the Revascularization of Patients With Acute Ischemic Stroke Secondary to Intracranial Large Vessel Occlusive Disease

This clinical evaluation is a prospective, single-arm, multi-center trial.

The purpose of this clinical evaluation is to assess the safety and effectiveness of the Penumbra System in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.

Read the detailed description

Purpose:

Conditions: Stroke
Being tested: Penumbra System
Keywords: Penumbra, Ischemic, Stroke, Intervention, Neurovascular, Thrombus, Embolectomy, Ischemic stroke
Medical subject headings: Stroke, Ischemia, Thrombosis, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Penumbra SystemDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Revascularization of the Occluded Target Vessel
Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System.
TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.
Measured: 3-Month Post-Procedure
Percentage of Participants With Device-related and Procedure-related Serious Adverse Events
Measured: 3-Month Post-Procedure

Secondary outcomes (4)

Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment
NIHSS is a 42 point scale to describe the neurological status of the patients:
0=no stroke; 1-15=minor to moderate stroke; 15-20=moderate/severe stroke; 21-42=severe stroke. The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.
Measured: Discharge or 30-Days Post-Procedure
Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment
The mRS is a scale to determine the activities of daily living of the patient with a score of 0 designating normal activities to a score of 6 designating death.
Measured: 90-Day
Percentage of Participants With All Cause Mortality
Measured: 90-Days Post-Treatment
Percentage of Participants With Symptomatic Hemorrhage
All treated patients were scanned by computed tomography (CT) at 24-hours post-procedure to detect the presence of intracranial hemorrhage.
Measured: 24-Hour Post-Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Nov 2007

First posted6 Jun 2006 (estimated)
Study startJun 2006
Primary completionJun 2007
Study completionNov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00334061
Sponsor's protocol ID: CLP 0676
Status last verified: Sep 2019
First submitted: 2 Jun 2006
Last updated: 18 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Penumbra™ Stroke System in the Revascularization of Patients With Acute Ischemic Stroke Secondary to Intracranial Large Vessel Occlusive Disease
ClinicalTrials.gov ID: NCT00334061
Acronym / sponsor ID: CLP 0676
Conditions: Stroke
Keywords: Penumbra, Ischemic, Stroke, Intervention, Neurovascular, Thrombus, Embolectomy, Ischemic stroke
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: Penumbra Inc.Industry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Jun 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 6 Jun 2006 (estimated)
Results: Posted 12 Jan 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This clinical evaluation is a prospective, single-arm, multi-center trial.

Detailed description

Purpose:

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Clinical signs consistent with acute ischemic stroke
18 to 79 years of age
Neurological deficit resulting in an NIH Stroke Scale (NIHSS) score > 8
TIMI 0 or TIMI I flow in vessels accessible to the Penumbra System
Signed informed consent

Key exclusion criteria (18 listed)

Evidence of rapidly improving neurological signs of stroke at time of enrollment
NIHSS > 30 or coma
Females who are pregnant
Vessel tortuosity too difficult to allow endovascular access
Known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an International Normalized Ratio (INR) > 3.0

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 System	Device	–

Primary outcome

Percentage of Participants With Revascularization of the Occluded Target Vessel
Time frame: 3-Month Post-Procedure
Revascularization is defined by a Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following use of the Penumbra System. TIMI scores are used to describe blood flow at the treated vessel with 0 designating no flow and 3 for normal flow.
Percentage of Participants With Device-related and Procedure-related Serious Adverse Events
Time frame: 3-Month Post-Procedure

4 secondary outcomes

Percentage of Participants With Either a 4-point Improvement on the National Institutes of Health Stroke Scale (NIHSS) at Discharge or a Modified Rankin Scale (mRS) Score of ≤ 2 at 30 Days After Treatment
Time frame: Discharge or 30-Days Post-Procedure
Percentage of Participants With a Modified Rankin Scale (mRS) Score of ≤ 2 at 90 Days Post Treatment
Time frame: 90-Day
Percentage of Participants With All Cause Mortality
Time frame: 90-Days Post-Treatment
Percentage of Participants With Symptomatic Hemorrhage
Time frame: 24-Hour Post-Procedure

Results and safety

Results posted to the registry on 12 Jan 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Penumbra System	125	125

Primary outcome: Percentage of Participants With Revascularization of the Occluded Target Vessel

Time frame: 3-Month Post-Procedure. Number. Unit: Percentage of Participants

Measure	Penumbra System n = 125
Value	81.2

Population analysed: Intention to Treat

Primary outcome: Percentage of Participants With Device-related and Procedure-related Serious Adverse Events

Time frame: 3-Month Post-Procedure. Number. Unit: Percentage of Participants

Measure	Penumbra System n = 125
Value	2.4

Population analysed: All adverse events were summarized by showing the number and percent of patients who reported the event. Events were also reported by relationship to the procedure or device. Causality of adverse events was adjudicated by a Clinical Events Committee. The denominator for the analyses was all enrolled patients.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Penumbra System	65 of 125 (52%)	125 of 125 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Penumbra System in people with 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 6 inclusion and 18 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 18 Sep 2019. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Revascularization of the Occluded Target Vessel (time frame: 3-Month Post-Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334061.

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 18 Sep 2019.