NCT06052969

Pulse Endovascular ReperFUSION for Acute Ischemic Stroke

PERFUSION AIS - Pulse Endovascular ReperFUSION for Acute Ischemic Stroke: An Early Feasibility Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Euphrates Vascular, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Ischemic Stroke AIS
• Cerebral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Pulse NanoMED System	The Pulse NanoMED System is comprised of iron nanoparticles and a small, portable, magnetic Workstation.

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-03-15
• Completion: 2026-03-15
• First posted: 2023-09-25
• Last updated: 2025-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study