Endovascular Therapy for Low NIHSS Ischemic Strokes

Summary

This study will test the hypothesis that patients presenting within 8 hours of onset with cerebral ischemia in the setting of proximal large vessel occlusions (LVO) and low baseline NIHSS scores (0-5) will have better 90-day clinical outcomes (mRS distribution) with immediate mechanical thrombectomy (iMT) compared to initial medical management (iMM).

Conditions

• Cerebral Ischemia

Interventions

DEVICE

Immediate mechanical thrombectomy(iMT) using EmboTrap Revascularization Device

Treatment initiation is defined as the date and time of arterial puncture. Femoral artery puncture will occur within 45 minutes of randomization and no longer than 90 minutes after the completion of the qualifying imaging. It must occur before 8 hours since the subject was last known well.The initial procedure will be performed using only the EmboTrap II Retriever for the first two passes, and a third pass is encouraged. Date and time of arterial puncture, revascularization, and procedure end will be recorded. It is expected that the interventional procedure will be completed within two hours of arterial access. All subjects, regardless of randomization arm, will receive best medical management based on current American Heart Association, Canadian, or European guidelines according to their geographic location.

COMBINATION_PRODUCT

Initial medical management (iMM)

Patients will receive standard medical therapy based on current AHA guidelines. For patients who are treated with intravenous tissue plasminogen activator (rtPA), the sites' post-rtPA protocol will be followed. Rescue mechanical thrombectomy (rMT) is allowed for patients initially assigned to iMM if they suffer major neurological worsening that clearly requires an intra-arterial intervention in the judgment of the treating team. All subjects, regardless of randomization arm, will receive best medical management based on current American Heart Association, Canadian, or European guidelines according to their geographic location.

Sponsors & Collaborators

• University of Calgary

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Heidelberg University

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Emory University

  lead OTHER

Principal Investigators

• Raul G Nogueira, MD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-05

Primary Completion

2025-09-30

Completion

2025-09-30

FDA Device

Yes

Countries

• United States
• Canada
• Germany

Study Locations