Pulse Endovascular ReperFUSION for Acute Ischemic Stroke

Conditions

• Acute Ischemic Stroke AIS
• Cerebral Arterial Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Pulse NanoMED System — DEVICE
  The Pulse NanoMED System is comprised of iron nanoparticles and a small, portable, magnetic Workstation.

Study Details

Prospective, multi-center, single-arm early feasibility study enrolling a minimum of 15 subjects at up to a minimum of 3 active investigational sites in the United States. The subjects must be diagnosed with acute ischemic stroke (AIS), must be post-mechanical thrombectomy, will have had intravenous thrombolytics, and have a visible MCA, ACA or PCA occlusive clot on initial angiographic imaging. Each subject will receive the Pulse NanoMED procedure after attempted neurovascular therapy to achieve better reperfusion.

Key Dates

Start date

Oct 1, 2023

Status verified

Aug 2025

Primary completion

Mar 15, 2026

Completion

Mar 15, 2026

Study Design

Enrollment

8 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Group/Cohort
  Subjects presenting to the emergency department with AIS, eligible for thrombolytic therapy, and with evidence of an occlusive clot by angiographic imaging will be considered for inclusion in the study. Post-thrombolytic therapy and mechanical thrombectomy eligible Subjects will receive the experimental NanoMED device.

Primary Outcome Measure

Primary Objective [ Time Frame: 24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure ]

Central Contacts

• Kristen Hlozek, PhD
  857-334-0851
  [email protected]

Locations (1)

Find similar trials in Columbia, SC

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