Acute Ischemic Stroke From Large Vessel OcclusionNCT01584609
A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
A study testing Penumbra System with Separator 3D and Penumbra System alone in people with Acute Ischemic Stroke From Large Vessel Occlusion, run by Penumbra Inc. at 8 sites in United States.
Trial summary
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke From Large Vessel Occlusion
- What is being tested?
- Penumbra System with Separator 3D and Penumbra System alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2012to Dec 2017
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- From 18 to 85 years of age
- Present with symptoms consistent with an acute ischemic stroke for revascularization within 8 hours from symptom onset
- Refractory to or not eligible for IV rtPA therapy., e.g., presenting between 0 and 3 hours from symptom onset AND contraindicated for IV rtPA, or presenting between 3 and 8 hours of symptom onset, or evidence of persistent occlusion from vascular imaging after IV rtPA
- Evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation
- NIH Stroke Scale (NIHSS) score 8 or more points
- Signed informed consent
Who cannot join
- History of stroke in the past 3 months.
- Females who are pregnant
- Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score 1 or higher
- Known severe allergy to contrast media
- Uncontrolled hypertension (defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg)
- CT evidence of the following conditions at randomization:
Show all 21Show fewer
- Significant mass effect with midline shift
- Large infarct region >1/3 of the middle cerebral artery territory
- Evidence of intracranial hemorrhage
- Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal
- Angiographic evidence of preexisting arterial injury
- Rapidly improving neurological status prior to enrollment
- Bilateral stroke
- Intracranial tumors
- Known history of cerebral aneurysm or arteriovenous malformation
- Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >1.7
- Baseline platelets <50,000
- Use of IV heparin in the past 48 hours with PTT >1.5 times the normalized ratio
- Baseline glucose <50mg/dL or >300mg/dL
- Life expectancy less than 90 days prior to stroke onset
- Participation in another clinical investigation that could confound the evaluation of the study device
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Grady Health System
Atlanta, Georgia, 30303
Kaleida Health
Buffalo, New York, 14209
Swedish Medical Center
Denver, Colorado, 80112
Hartford Hospital
Hartford, Connecticut, 6106
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Hoag Hospital
Newport Beach, California, 92658
St. Joseph Hospital- Healtheast
Saint Paul, Minnesota, 55102
Stony Brook University Hospital
Stony Brook, New York, 11794-8122
About this study
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D. Each treated patient will be followed and assessed for 3 months after randomization. Up to 230 evaluable patients at up to 50 centers presenting with acute ischemic stroke in vessels accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Penumbra System with the Separator 3D for the revascularization of large vessel occlusion is not inferior to the Penumbra System alone.
- Being tested
- Penumbra System with Separator 3D, Penumbra System alone
- Keywords
- ischemic stroke, large vessel occlusion, mechanical thrombectomy, revascularization, Penumbra System, Separator 3D
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penumbra System with Separator 3DDevice
The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
Penumbra System aloneDevice
The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
| Study group | Role | What they receive |
|---|---|---|
| Penumbra System with Separator 3D | Experimental | Not described Receives: Device: Penumbra System with Separator 3D |
| Penumbra System alone | Active comparator | Not described Receives: Device: Penumbra System alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Angiographic Revascularization of the Occluded Target Vessel
Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3
Measured: At immediate post-procedure
Number of Device-related Serious Adverse Events
Measured: Within 24 hours post-procedure
Number of Procedure-related Serious Adverse Event
Measured: Within 24 hours post-procedure
Secondary outcomes (5)
Good Clinical Outcome at 30 Days
Defined by a 10 points or more improvement in the NIHSS at Discharge, a NIHSS score of 0-1 at Discharge; or a 30-day mRS score of 0-2. The NIHSS is a stroke scale that measures impairment caused by stroke. The Modified Rankin scale (mRS) measures neurological disability or dependence for stroke patients.
Measured: 30 days post-procedure
Number of Participants With 90 Day mRS Score 0-2
Measured: at 90 days post-procedure
All Cause Mortality
Measured: At 90 days post-procedure
Number of Symptomatic Intracranial Hemorrhage
Measured: Within 24 hours post-procedure
Good Neurological Outcome at 90 Days
Defined by an mRS score of 0-2, or equal to the pre-stroke mRS score if the pre-stroke mRS score was higher than 2, or an improvement of 10 or more points on the NIHSS score
Measured: At 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 posted25 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2017
- Study completionDec 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic Stroke From Large Vessel OcclusionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Don Frei, MD, Principal investigator, Swedish Medical Center, Denver, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584609
- Sponsor's protocol ID
- CLP 4853
- Other IDs
- CLP 4853
- Status last verified
- Aug 2018
- First submitted
- 23 Apr 2012
- Last updated
- 13 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nogueira RG, Frei D, Kirmani JF, Zaidat O, Lopes D, Turk AS 3rd, Heck D, Mason B, Haussen DC, Levy EI, Mehta S, Lazzaro M, Chen M, Dorfler A, Yoo AJ, Derdeyn CP, Schwamm L, Langer D, Siddiqui A; Penumbra Separator 3D Investigators. Safety and Efficacy of a 3-Dimensional Stent Retriever With Aspiration-Based Thrombectomy vs Aspiration-Based Thrombectomy Alone in Acute Ischemic Stroke Intervention: A Randomized Clinical Trial. JAMA Neurol. 2018 Mar 1;75(3):304-311. doi: 10.1001/jamaneurol.2017.3967.
PubMed 29296999
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01584609
- Acronym / sponsor ID
- CLP 4853
- Keywords
- ischemic stroke, large vessel occlusion, mechanical thrombectomy, revascularization, Penumbra System, Separator 3D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Posted 13 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D. Each treated patient will be followed and assessed for 3 months after randomization. Up to 230 evaluable patients at up to 50 centers presenting with acute ischemic stroke in vessels accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Penumbra System with the Separator 3D for the revascularization of large vessel occlusion is not inferior to the Penumbra System alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Penumbra System with Separator 3D | Experimental | Device: Penumbra System with Separator 3D |
| Penumbra System alone | Active comparator | Device: Penumbra System alone |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- From 18 to 85 years of age
- Present with symptoms consistent with an acute ischemic stroke for revascularization within 8 hours from symptom onset
- Refractory to or not eligible for IV rtPA therapy., e.g., presenting between 0 and 3 hours from symptom onset AND contraindicated for IV rtPA, or presenting between 3 and 8 hours of symptom onset, or evidence of persistent occlusion from vascular imaging after IV rtPA
- Evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation
- NIH Stroke Scale (NIHSS) score 8 or more points
Key exclusion criteria (21 listed)
- History of stroke in the past 3 months.
- Females who are pregnant
- Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score 1 or higher
- Known severe allergy to contrast media
- Uncontrolled hypertension (defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg)
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 with Separator 3DThe Separator 3D is an additional Separator with a new tip configuration for the Penumbra System. | Device | Penumbra System with Separator 3D |
| Penumbra System aloneThe Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel. | Device | Penumbra System alone |
Primary outcome
Number of Participants With Angiographic Revascularization of the Occluded Target Vessel
Time frame: At immediate post-procedure
Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3
Number of Device-related Serious Adverse Events
Time frame: Within 24 hours post-procedure
Number of Procedure-related Serious Adverse Event
Time frame: Within 24 hours post-procedure
5 secondary outcomes
Good Clinical Outcome at 30 Days
Time frame: 30 days post-procedure
Number of Participants With 90 Day mRS Score 0-2
Time frame: at 90 days post-procedure
All Cause Mortality
Time frame: At 90 days post-procedure
Number of Symptomatic Intracranial Hemorrhage
Time frame: Within 24 hours post-procedure
Good Neurological Outcome at 90 Days
Time frame: At 90 days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29296999Nogueira RG, Frei D, Kirmani JF, Zaidat O, Lopes D, Turk AS 3rd, Heck D, Mason B, Haussen DC, Levy EI, Mehta S, Lazzaro M, Chen M, Dorfler A, Yoo AJ, Derdeyn CP, Schwamm L, Langer D, Siddiqui A; Penumbra Separator 3D Investigators. Safety and Efficacy of a 3-Dimensional Stent Retriever With Aspiration-Based Thrombectomy vs Aspiration-Based Thrombectomy Alone in Acute Ischemic Stroke Intervention: A Randomized Clinical Trial. JAMA Neurol. 2018 Mar 1;75(3):304-311. doi: 10.1001/jamaneurol.2017.3967.
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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.
Don Frei, MD principal investigator
Swedish Medical Center, Denver, CO
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penumbra System with Separator 3D and Penumbra System alone in people with Acute Ischemic Stroke From Large Vessel Occlusion, run by Penumbra Inc. at 8 sites 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 21 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Yes. Results are posted in the registry (first posted 13 Sep 2018). 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?
Number of Participants With Angiographic Revascularization of the Occluded Target Vessel (time frame: At immediate post-procedure). 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?
On the ClinicalTrials.gov record for NCT01584609, which also lists 1 linked publication.
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 13 Sep 2018.