Pulse treatment for acute ischemic stroke
Official title: PERFUSION AIS - Pulse Endovascular ReperFUSION for Acute Ischemic Stroke: An Early Feasibility Clinical Study
Run by Euphrates Vascular, Inc. · NCT06052969 · Data updated 2026-11-12
This study is testing a new treatment called the Pulse NanoMED System for people who have had an acute ischemic stroke to see if it can help improve blood flow to the brain after they receive standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 8 (estimated) |
| Sponsor | Euphrates Vascular, Inc. Industry-sponsored |
| Locations | 1 site (Columbia, South Carolina) |
| Status | Recruiting |
| Started | October 1, 2023 |
| Main results expected | March 15, 2026 |
| Study ends | March 15, 2026 |
| Registry record updated | August 7, 2025 |
| Trial ID | NCT06052969 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 85 who have experienced a large vessel occlusion and have undergone mechanical thrombectomy with residual occlusion.
✕Probably not a fit
Patients with significant pre-stroke functional disability or those who do not meet the specific eligibility criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of the Pulse NanoMED System in patients diagnosed with acute ischemic stroke who have undergone mechanical thrombectomy. It is a prospective, multi-center, single-arm early feasibility study that aims to enroll at least 15 subjects across a minimum of three investigational sites in the United States. Participants will receive the Pulse NanoMED procedure after standard neurovascular therapy to improve blood flow to the brain. The study focuses on patients with specific occlusive clot conditions as identified through angiographic imaging.
Why it matters
Potential benefit: If successful, this treatment could significantly improve reperfusion outcomes for patients suffering from acute ischemic stroke.
How similar studies have gone: While this approach is novel, similar studies have shown promise in improving outcomes for acute ischemic stroke patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. The participant is ≥ 18 years old and less than 85 years old. 3. 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. 4. 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). 5. Post-MT and has had thrombolytic therapy \<9 hours prior to the proposed start time of System therapy 6. No significant pre-stroke functional disability (modified Rankin scale 0-1) 7. Baseline NIHSS≥6 8. ASPECTS \>6 on non-contrast CT (NCCT) scan if symptoms lasting \<8 hours 9. CT-Perfusion (CTP) is optional, if performed, should demonstrate rCBF \<30% lesion volume ≤70 mL. 10. Imaging should be obtained within 75 minutes of the onset of mechanical thrombectomy. Exclusion Criteria: 1. NIHSS score on admission \>25 2. Use of carotid artery stents during the endovascular procedure requiring dual antiplatelet therapy 3. Female who is pregnant or lactating or has a positive pregnancy test at the time of admission 4. Current participation in another investigational drug or device treatment study 5. Known allergy or sensitivity to iron 6. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency 7. Known coagulopathy, INR \>1.7, or use of novel anticoagulants \<12h from symptom onset 8. Known Platelets \<100,000 9. Known Renal Failure as defined by a serum creatinine \>3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate \[GFR\] \<30 10. Subject who requires hemodialysis or peritoneal dialysis or who has a contraindication to angiogram for whatever reason 11. Any hemorrhage on CT/MRI 12. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal. 13. Suspicion of aortic dissection 14. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol. 15. History of life-threatening allergy (more than rash) to contrast medium 16. SBP \>185mmHg or DBP \>110mmHg refractory to treatment 17. Serious, advanced, terminal illness with anticipated life expectancy \<6 months 18. Pre-existing neurological or psychiatric disease that would confound evaluation 19. Presumed vasculitis or septic embolization 20. Known sensitivity or allergy to contrast materials that cannot be previously treated properly 21. The subject takes Coumadin and its interruption could compromise their safety 22. Known allergy or contraindication to double antiplatelet treatment 23. Known hypersensitivity or contraindication to iron or polyethylene glycol-based agents 24. Known contraindication to MRI (examples include, but are not known, implantable cardioverter-defibrillator, pacemaker, clip-on or spiral aneurysm, neurostimulator) 25. The physical geometry of the subject that prevents the placement of the magnet 26. The subject has signs or symptoms of systemic infection/sepsis (temperature of ≥38.0 Celsius and/or white blood cell count of ≥12,000 cells/uL). If the subject has a localized infection, such as cellulitis or osteomyelitis, or the infection is properly treated and controlled, according to the discretion of the researcher, the patient can enroll 27. Known or suspected cardiovascular condition that causes a secondary or tertiary heart block, tachycardia-bradycardia syndrome, or symptomatic postural hypotension requiring medical intervention 28. Known or suspected symptomatic hemochromatosis or hemosiderosis 29. Known or suspected liver disease, such as hepatitis and/or cirrhosis 30. The subject has received iron replacement therapy or contrast for iron-based MRI in the previous 30 days
Where it's running
-
University of South Carolina - Prisma
Columbia, South Carolina, United States Recruiting
Study contacts
- Study coordinator: Kristen Hlozek, PhD
- Email: kristen@euphratesvascular.com
- Phone: 857-334-0851
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Mobilisation After Endovascular Stroke Treatment
This study checks whether moving around 12 hours after endovascular stroke treatment is as safe as moving around 24 hours for people with an acute ischemic stroke.
-
Intra-arterial Thrombolysis After Endovascular Thrombectomy in AIS
This trial tests whether giving intra-arterial thrombolysis with tenecteplase or alteplase after endovascular thrombectomy helps improve recovery in adults with acute ischemic stroke.
-
Real-world performance and safety of the Penumbra System in acute ischemic stroke
This project will test how the Penumbra mechanical thrombectomy system performs and how safe it is in adults aged 18–75 who have acute ischemic stroke and are eligible for clot removal.
-
Balloon guide catheter versus conventional guide catheter for clot removal in ischemic stroke
This study will test whether a balloon guide catheter or a conventional guide catheter works better for adults having a thrombectomy to treat an acute ischemic stroke.
-
IV infusions of human umbilical cord mesenchymal stem cells for acute ischemic stroke (Phase IIa)
This Phase IIa test will see if one or multiple IV infusions of human umbilical cord mesenchymal stem cells help adults with recent acute ischemic stroke recover better and are safe.
-
One-stop approach for rapid start of endovascular clot removal
This trial will test whether taking eligible adults with suspected large- or medium-vessel ischemic stroke straight to the angiography suite for imaging and treatment gets clot-removal therapy started faster and improves outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.