Pulse Endovascular ReperFUSION for Acute Ischemic Stroke

Recruiting now · Not applicable

Conditions studied: Acute Ischemic Stroke AIS, Cerebral Arterial Disease

In brief

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 facts

Study ID

NCT06052969

Run by

Euphrates Vascular, Inc.

People needed

8

Starts

2023-10-01

Expected to finish

2026-03-15

Last updated by the study team

2025-08-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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
• SBP >185mmHg or DBP >110mmHg refractory to treatment
• Serious, advanced, terminal illness with anticipated life expectancy <6 months
• Pre-existing neurological or psychiatric disease that would confound evaluation
• Presumed vasculitis or septic embolization
• Known sensitivity or allergy to contrast materials that cannot be previously treated properly
• The subject takes Coumadin and its interruption could compromise their safety
• Known allergy or contraindication to double antiplatelet treatment
• Known hypersensitivity or contraindication to iron or polyethylene glycol-based agents
• Known contraindication to MRI (examples include, but are not known, implantable cardioverter-defibrillator, pacemaker, clip-on or spiral aneurysm, neurostimulator)
• The physical geometry of the subject that prevents the placement of the magnet

Where it is running

• University of South Carolina - Prisma — Columbia, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.