NCT06961487Enrolling by invitation
Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy
Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy (OUTER LIMITS)
Source: ClinicalTrials.gov · Last updated 8 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- 26 Jul 2024
- Primary completion date
- May 2028
- Lead sponsor
- Stanford University
- Diseases
- Stroke
- NCT number
- NCT06961487
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 26 Jul 2024 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treated with tPA or TNK \>4.5 hours after time last known well
- Current participation in another investigational drug or device study
Other illness
- 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
- Known allergy to iodine that precludes an endovascular procedure
- Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
- Severe, sustained hypertension (SBP \>185 mmHg or DBP \>110 mmHg)
- 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
Lab values
- Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol)
- Baseline platelet count \< 50,000/uL
Other
- Pregnant
- Unable to undergo a contrast brain perfusion scan with either MRI or CT
- Presumed septic embolus; suspicion of bacterial endocarditis
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.