Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06961487
Status
Enrolling By Invitation

Conditions

  • Ischemic Stroke, Acute
  • Stroke, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

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 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

Study Details

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.

Key Dates

Start date
Jul 26, 2024
Status verified
Mar 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Endovascular Thrombectomy
    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.
  • No Intervention: Medical Management
    Standard medical therapy, based on current AHA guidelines

Primary Outcome Measure

Disability as measured on the modified Rankin Score [ Time Frame: 90 day ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304-

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By research site
Stanford University· Palo Alto, CA

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