Pulse treatment for acute ischemic stroke

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Euphrates Vascular, Inc. (Industry-sponsored)
• Locations: 1 site (Columbia, South Carolina)
• Trial ID: NCT06052969 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: While this approach is novel, similar studies have shown promise in improving outcomes for acute ischemic stroke patients.

Eligibility 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 this trial is running

Columbia, South Carolina

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

Study contacts

• Study coordinator: Kristen Hlozek, PhD

Conditions Acute Ischemic Stroke AIS; Cerebral Arterial Disease; MicroBeads; Pulse NanoMed System