Stroke, AcuteOUTER LIMITSNCT06961487
Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy
A study testing EndovascularThrombectomy and Endovascular thrombectomy with any FDA-approved device in people with Stroke, Acute and Ischemic Stroke, Acute, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of endovascular thrombectomy in both an early and extended time window in patients with large strokes due to large artery occlusion. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Acute, Ischemic Stroke, Acute
- What is being tested?
- EndovascularThrombectomy and Endovascular thrombectomy with any FDA-approved device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2024to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signs and symptoms consistent with an acute anterior circulation ischemic stroke and associated brain imaging
- Baseline NIHSSS is ≥10 and remains ≥10 immediately prior to randomization
- Treatment can be initiated within 24 hours of stroke onset or time last known well and within 120 minutes of completion of qualifying imaging
- Functionally independent prior to stroke onset
- Patient/ Legally Authorized Representative has signed the Informed Consent form.
Who cannot join
- Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months.
- Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
- Pregnant
- Unable to undergo a contrast brain perfusion scan with either MRI or CT
- Known allergy to iodine that precludes an endovascular procedure
- Treated with tPA or TNK >4.5 hours after time last known well
Show all 19Show fewer
- Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
- Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol)
- Baseline platelet count < 50,000/uL
- Severe, sustained hypertension (SBP >185 mmHg or DBP >110 mmHg)
- Current participation in another investigational drug or device study
- Presumed septic embolus; suspicion of bacterial endocarditis
- Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
- NEUROIMAGING Exclusion:
- Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
- Significant mass effect with midline shift
- Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
- Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
- Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy (OUTER LIMITS)
The purpose of this study is to assess the safety and efficacy of endovascular thrombectomy in both an early and extended time window in patients with large strokes due to large artery occlusion.
Read the detailed description
This is a pilot prospective randomized trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion who present with an eligible large ischemic core lesion, and who can be treated within 24 hours of stroke onset. The results of this pilot study will be used as preliminary data for a larger NIH-funded multi-center randomized trial to address the knowledge gaps in the management of this patient population.
Eligible patients will be randomized 1:1 to either:
Endovascular therapy plus medical therapy (based on current AHA guidelines)
or
Medical therapy (based on current AHA guidelines)
Endovascular Therapy: Patients randomized to endovascular therapy will be treated with aspiration thrombectomy devices and suction thrombectomy systems approved by the FDA for use in this study. Standard medical therapy, based on current AHA guidelines, will also be provided.
Medical Therapy: Patients randomized to medical therapy will receive standard medical therapy based on current AHA guidelines.
The researchers hope to learn if endovascular therapy plus standard medical therapy in this patient population leads to less disability after stroke than standard medical therapy alone.
- Conditions
- Stroke, Acute, Ischemic Stroke, Acute
- Being tested
- EndovascularThrombectomy, Endovascular thrombectomy with any FDA-approved device
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndovascularThrombectomyProcedure or surgery
Endovascular thrombectomy is a minimally invasive procedure that uses catheters and devices to remove blood clots, restoring blood flow to the brain. The procedure involves inserting a catheter (a long, thin tube) into an artery, usually in the groin, and guiding it through the blood vessels to the site of the blocked artery/blood clot in the brain. After the catheter reaches the affected area, a specialized device is guided through the catheter to capture and remove the clot.
Endovascular thrombectomy with any FDA-approved deviceDevice
Also called Endovascular Therapy, Endovascular Recanalization Therapy, EVT
The following FDA approved thrombectomy devices will be included:
Stryker Neurovascular Products:
- AXS Vecta 74 Aspiration System
- AXS Vecta Aspiration System (AXS Vecta 71 Aspiration Catheter and AXS Vecta 74 Aspiration Catheter)
- AXS Vecta Intermediate Catheters (AXS Vecta 71 Intermediate Catheter \& AXS Vecta 74 Intermediate Catheter)
- Trevo XP ProVue Retriever, 3x20 and 4x20
- Trevo XP ProVue Retriever, 4x30
- Trevo XP ProVue Retriever, 6x25
Medtronic Products:
Solitaire X Revascularization Devices:
- Solitaire X 4x20, 4x40, 6x40
- Solitaire X 3x20, 3x40
Aspiration catheters:
- React 68
- React 71
- REACT-71-115 \& REACT-71-125
MicroVention Inc. Products:
- SOFIA, Aspiration pump and tubing kit
- SOFIA Plus Aspiration catheter
- BOBBY balloon guide catheter
- ERIC retrieval device
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Thrombectomy | Other | Treatment with one or more thrombectomy devices (only the devices listed in the study protocol are approved for use) plus standard medical therapy for patients with acute ischemic anterior circulation strokes due to large artery occlusion who present with an eligible large ischemic core lesion, and who can be treated within 24 hours of stroke onset. Receives: Procedure: EndovascularThrombectomy; Device: Endovascular thrombectomy with any FDA-approved device |
| Medical Management | No intervention | Standard medical therapy, based on current AHA guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability as measured on the modified Rankin Score
The modified Rankin Scale is a 7 point scale that measures degree of disability after a stroke. The scale range is as follows:
0: No symptoms at all
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead
Measured: 90 day
Secondary outcomes (2)
Percentage of patients with modified Rankin Scale 0-3
The modified Rankin Scale is a 7 point scale that measures degree of disability after a stroke. The scale range is as follows:
0: No symptoms at all
- No significant disability despite symptoms; able to carry out all usual duties and activities
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- Moderate disability; requiring some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
- Dead
Measured: 90 day
Percentage of patients requiring hemicraniectomy
A surgical procedure that involves removing a large bone flap to relieve pressure on the brain due to swelling
Measured: from admission to discharge; up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start26 Jul 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory W Albers, Stanford University
- Investigators
- Gregory Albers, MD, Principal investigator, Stanford UniversityJeremy Heit, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961487
- Sponsor's protocol ID
- 74948
- Acronym
- OUTER LIMITS
- Status last verified
- Mar 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: we currently do not have a plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy (OUTER LIMITS)
- ClinicalTrials.gov ID
- NCT06961487
- Acronym / sponsor ID
- OUTER LIMITS / 74948
- Conditions
- Stroke, Acute, Ischemic Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 8 May 2025 (actual)
- 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 purpose of this study is to assess the safety and efficacy of endovascular thrombectomy in both an early and extended time window in patients with large strokes due to large artery occlusion.
Detailed description
This is a pilot prospective randomized trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion who present with an eligible large ischemic core lesion, and who can be treated within 24 hours of stroke onset. The results of this pilot study will be used as preliminary data for a larger NIH-funded multi-center randomized trial to address the knowledge gaps in the management of this patient population.
Eligible patients will be randomized 1:1 to either:
Endovascular therapy plus medical therapy (based on current AHA guidelines)
or
Medical therapy (based on current AHA guidelines)
Endovascular Therapy: Patients randomized to endovascular therapy will be treated with aspiration thrombectomy devices and suction thrombectomy systems approved by the FDA for use in this study. Standard medical therapy, based on current AHA guidelines, will also be provided.
Medical Therapy: Patients randomized to medical therapy will receive standard medical therapy based on current AHA guidelines.
The researchers hope to learn if endovascular therapy plus standard medical therapy in this patient population leads to less disability after stroke than standard medical therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Thrombectomy | Other | Procedure: EndovascularThrombectomy, Device: Endovascular thrombectomy with any FDA-approved deviceTreatment with one or more thrombectomy devices (only the devices listed in the study protocol are approved for use) plus standard medical therapy for patients with acute ischemic anterior circulation strokes due to large artery occlusion who present with an eligible large ischemic core lesion, and who can be treated within 24 hours of stroke onset. |
| Medical Management | No intervention | –Standard medical therapy, based on current AHA guidelines |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signs and symptoms consistent with an acute anterior circulation ischemic stroke and associated brain imaging
- Baseline NIHSSS is ≥10 and remains ≥10 immediately prior to randomization
- Treatment can be initiated within 24 hours of stroke onset or time last known well and within 120 minutes of completion of qualifying imaging
- Functionally independent prior to stroke onset
- Patient/ Legally Authorized Representative has signed the Informed Consent form.
Key exclusion criteria (19 listed)
- Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months.
- Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
- Pregnant
- Unable to undergo a contrast brain perfusion scan with either MRI or CT
- Known allergy to iodine that precludes an endovascular procedure
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 |
|---|---|---|
| EndovascularThrombectomyEndovascular thrombectomy is a minimally invasive procedure that uses catheters and devices to remove blood clots, restoring blood flow to the brain. The procedure involves inserting a catheter (a long, thin tube) into an artery, usually in the groin, and guiding it through the blood vessels to the site of the blocked artery/blood clot in the brain. After the catheter reaches the affected area, a specialized device is guided through the catheter to capture and remove the clot. | Procedure or surgery | Endovascular Thrombectomy |
| Endovascular thrombectomy with any FDA-approved deviceAlso: Endovascular Therapy, Endovascular Recanalization Therapy, EVTThe following FDA approved thrombectomy devices will be included: Stryker Neurovascular Products: * AXS Vecta 74 Aspiration System * AXS Vecta Aspiration System (AXS Vecta 71 Aspiration Catheter and AXS Vecta 74 Aspiration Catheter) * AXS Vecta Intermediate Catheters (AXS Vecta 71 Intermediate Catheter \& AXS Vecta 74 Intermediate Catheter) * Trevo XP ProVue Retriever, 3x20 and 4x20 * Trevo XP ProVue Retriever, 4x30 * Trevo XP ProVue Retriever, 6x25 Medtronic Products: Solitaire X Revascularization Devices: * Solitaire X 4x20, 4x40, 6x40 * Solitaire X 3x20, 3x40 Aspiration catheters: * React 68 * React 71 * REACT-71-115 \& REACT-71-125 MicroVention Inc. Products: * SOFIA, Aspiration pump and tubing kit * SOFIA Plus Aspiration catheter * BOBBY balloon guide catheter * ERIC retrieval device | Device | Endovascular Thrombectomy |
Primary outcome
Disability as measured on the modified Rankin Score
Time frame: 90 day
The modified Rankin Scale is a 7 point scale that measures degree of disability after a stroke. The scale range is as follows: 0: No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
2 secondary outcomes
Percentage of patients with modified Rankin Scale 0-3
Time frame: 90 day
Percentage of patients requiring hemicraniectomy
Time frame: from admission to discharge; up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No. we currently do not have a plan to share IPD with other researchers
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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.
Gregory Albers, MD principal investigator
Stanford University
Jeremy Heit, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndovascularThrombectomy and Endovascular thrombectomy with any FDA-approved device in people with Stroke, Acute and Ischemic Stroke, Acute, run by Stanford University 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 5 inclusion and 19 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: enrolling by invitation, as of the sponsor's last update on 8 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Disability as measured on the modified Rankin Score (time frame: 90 day). 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 8 May 2025.