Pulse Endovascular ReperFUSION for Acute Ischemic Stroke

NCT06052969 | Recruiting DMC FDA Device

• 2 other identifiers: MED-CLN-001PG220131/S001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MicroBeads; Pulse NanoMed System

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  To test the safety and feasibility of the Pulse NanoMED System in ischemic stroke patients. The potential clinical benefit of early recanalization will be visually assessed by a core laboratory by comparing baseline DSA, CTA, or MRA images with images taken at set timepoints.

  24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure

Secondary Outcomes (1)

• Secondary Objective

  24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure

Study Arms (1)

Group/Cohort

EXPERIMENTAL

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.

Device: Pulse NanoMED System

Interventions

Pulse NanoMED System DEVICE

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

Group/Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) or an acceptable patient surrogate.
• The participant is ≥ 18 years old and less than 85 years old.
• Patients with symptomatic large vessel occlusion (LVO) who undergo MT as part of their standard of care and have residual occlusion involving the anterior, middle or posterior cerebral arteries resulting in a eTICI score greater than 2b50 at the end of the procedure with three or less MT device passes.
• Estimated delay to onset of rescue Pulse NanoMED MicroBead administration \<9 hours from symptom onset, defined as the point in time the patient was last known well (LKW).
• Post-MT and has had thrombolytic therapy \<9 hours prior to the proposed start time of System therapy
• No significant pre-stroke functional disability (modified Rankin scale 0-1)
• Baseline NIHSS≥6
• ASPECTS \>6 on non-contrast CT (NCCT) scan if symptoms lasting \<8 hours
• CT-Perfusion (CTP) is optional, if performed, should demonstrate rCBF \<30% lesion volume ≤70 mL.
• Imaging should be obtained within 75 minutes of the onset of mechanical thrombectomy.

You may not qualify if:

• NIHSS score on admission \>25
• Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy
• Female who is pregnant or lactating or has a positive pregnancy test at the time of admission
• Current participation in another investigational drug or device treatment study
• Known allergy or sensitivity to iron
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
• Known coagulopathy, INR \>1.7, or use of novel anticoagulants \<12h from symptom onset
• Known Platelets \<100,000
• Known Renal Failure as defined by a serum creatinine \>3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate \[GFR\] \<30
• Subject who requires hemodialysis or peritoneal dialysis or who has a contraindication to angiogram for whatever reason
• Any hemorrhage on CT/MRI
• Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.
• Suspicion of aortic dissection
• Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol.
• History of life-threatening allergy (more than rash) to contrast medium

Sponsors & Collaborators

• Euphrates Vascular, Inc.: lead

Study Sites (1)

University of South Carolina - Prisma

Columbia, South Carolina, 29203, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Arterial Diseases

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kristen Hlozek, PhD

CONTACT

857-334-0851; kristen@euphratesvascular.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, single-arm early feasibility study.

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 25, 2023
• Study Start: October 1, 2023
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

US (1)