ENROLLING_BY_INVITATION

Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy (OUTER LIMITS)

Quick Facts

Study Start:2024-07-26

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ENROLLING_BY_INVITATION

Study ID

NCT06961487

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Signs and symptoms consistent with an acute anterior circulation ischemic stroke and associated brain imaging 2. Baseline NIHSSS is ≥10 and remains ≥10 immediately prior to randomization 3. Treatment can be initiated within 24 hours of stroke onset or time last known well and within 120 minutes of completion of qualifying imaging 4. Functionally independent prior to stroke onset 5. Patient/ Legally Authorized Representative has signed the Informed Consent form.	1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months. 2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations 3. Pregnant 4. Unable to undergo a contrast brain perfusion scan with either MRI or CT 5. Known allergy to iodine that precludes an endovascular procedure 6. Treated with tPA or TNK \>4.5 hours after time last known well 7. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS 8. Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol) 9. Baseline platelet count \< 50,000/uL 10. Severe, sustained hypertension (SBP \>185 mmHg or DBP \>110 mmHg) 11. Current participation in another investigational drug or device study 12. Presumed septic embolus; suspicion of bacterial endocarditis 13. 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. 1. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation 2. Significant mass effect with midline shift 3. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection 4. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device 5. 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).

Inclusion Criteria

Exclusion Criteria

1. Signs and symptoms consistent with an acute anterior circulation ischemic stroke and associated brain imaging
2. Baseline NIHSSS is ≥10 and remains ≥10 immediately prior to randomization
3. Treatment can be initiated within 24 hours of stroke onset or time last known well and within 120 minutes of completion of qualifying imaging
4. Functionally independent prior to stroke onset
5. Patient/ Legally Authorized Representative has signed the Informed Consent form.

1. Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 6 months.
2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
3. Pregnant
4. Unable to undergo a contrast brain perfusion scan with either MRI or CT
5. Known allergy to iodine that precludes an endovascular procedure
6. Treated with tPA or TNK \>4.5 hours after time last known well
7. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
8. Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol)
9. Baseline platelet count \< 50,000/uL
10. Severe, sustained hypertension (SBP \>185 mmHg or DBP \>110 mmHg)
11. Current participation in another investigational drug or device study
12. Presumed septic embolus; suspicion of bacterial endocarditis
13. 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.
1. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
2. Significant mass effect with midline shift
3. Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
4. Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
5. 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).

Contacts and Locations

Principal Investigator

Gregory Albers, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Jeremy Heit, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University

Palo Alto, California, 94304

United States

Collaborators and Investigators

Sponsor: Stanford University

Gregory Albers, MD, PRINCIPAL_INVESTIGATOR, Stanford University
Jeremy Heit, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-26

Study Completion Date2028-05

Study Record Updates

Study Start Date2024-07-26

Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

Stroke, Acute
Ischemic Stroke, Acute