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Endovascular Therapy for Large Core Patients With Uncertain Response to Thrombectomy

NCT06961487 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-08

No results posted yet for this study

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

Interventions

PROCEDURE

EndovascularThrombectomy

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.

DEVICE

Endovascular thrombectomy with any FDA-approved 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

Sponsors & Collaborators

Principal Investigators

  • Gregory Albers, MD · Stanford University

  • Jeremy Heit, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-26
Primary Completion
2028-05-31
Completion
2028-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06961487 on ClinicalTrials.gov