Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy

NCT06961487 | Enrolling By Invitation FDA Device

• 1 other identifier: 74948
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Acute; Ischemic Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• 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 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

  90 day

Secondary Outcomes (2)

• Percentage of patients with modified Rankin Scale 0-3

  90 day

• Percentage of patients requiring hemicraniectomy

  from admission to discharge; up to 14 days

Study Arms (2)

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.

Procedure: EndovascularThrombectomy; Device: Endovascular thrombectomy with any FDA-approved device

Medical Management

NO INTERVENTION

Standard medical therapy, based on current AHA guidelines

Interventions

EndovascularThrombectomy PROCEDURE

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

Endovascular thrombectomy with any FDA-approved device DEVICE

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

Also known as: Endovascular Therapy, Endovascular Recanalization Therapy, EVT

Endovascular Thrombectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
• Significant mass effect with midline shift

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gregory Albers, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jeremy Heit, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: July 26, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)