Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06052969

Pulse Endovascular ReperFUSION for Acute Ischemic Stroke

Led by Euphrates Vascular, Inc. · Updated on 2025-08-07

8

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Pulse Endovascular ReperFUSION for Acute Ischemic Stroke

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The participant provides written informed consent using an approved Informed Consent Form (ICF) or via an acceptable patient surrogate.
  • The participant is 18 years or older and younger than 85 years.
  • Patients with symptomatic large vessel occlusion (LVO) who undergo mechanical thrombectomy with residual occlusion in the anterior, middle, or posterior cerebral arteries, with an eTICI score greater than 2b50 and three or fewer device passes.
  • Estimated time from symptom onset to planned Pulse NanoMED administration is less than 9 hours.
  • Post-mechanical thrombectomy and received thrombolytic therapy less than 9 hours before starting system therapy.
  • No significant pre-stroke disability (modified Rankin scale 0-1).
  • Baseline NIH Stroke Scale score of 6 or higher.
  • ASPECTS score greater than 6 on non-contrast CT scan if symptoms last less than 8 hours.
  • Optional CT perfusion showing rCBF less than 30% lesion volume 70 mL or less.
  • Imaging obtained within 75 minutes of mechanical thrombectomy onset.
Not Eligible

You will not qualify if you...

  • NIH Stroke Scale score above 25 on admission.
  • Use of carotid artery stents requiring dual antiplatelet therapy during endovascular procedure.
  • Female who is pregnant, lactating, or has a positive pregnancy test at admission.
  • Current participation in another investigational drug or device study.
  • Known allergy or sensitivity to iron.
  • Known bleeding disorders, coagulation factor deficiencies, or coagulopathy.
  • INR greater than 1.7 or recent use of novel anticoagulants within 12 hours of symptom onset.
  • Platelet count below 100,000.
  • Known renal failure with serum creatinine above 3.0 mg/dl or GFR less than 30.
  • Requires dialysis or has contraindication to angiogram.
  • Any hemorrhage seen on CT or MRI.
  • Suspected subarachnoid hemorrhage.
  • Suspicion of aortic dissection.
  • Recent illicit drug use or alcohol abuse.
  • History of severe allergy to contrast medium.
  • Uncontrolled high blood pressure above 185/110 mmHg.
  • Serious terminal illness with life expectancy less than 6 months.
  • Pre-existing neurological or psychiatric disease confounding evaluation.
  • Presumed vasculitis or septic embolization.
  • Known allergy or contraindication to contrast or double antiplatelet treatment.
  • Contraindications to MRI.
  • Physical issues preventing magnet placement.
  • Signs or symptoms of systemic infection or sepsis unless controlled.
  • Cardiovascular conditions causing heart block or postural hypotension.
  • Known or suspected hemochromatosis or hemosiderosis.
  • Known or suspected liver disease.
  • Iron replacement therapy or iron-based MRI contrast within previous 30 days.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of South Carolina - Prisma

Columbia, South Carolina, United States, 29203

Actively Recruiting

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Research Team

K

Kristen Hlozek, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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