Actively Recruiting
PERFUSION AIS - Pulse Endovascular ReperFUSION for Acute Ischemic Stroke: An Early Feasibility Clinical Study
Led by Euphrates Vascular, Inc. · Updated on 2025-08-07
8
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an early feasibility trial involving adults who have experienced an acute ischemic stroke (AIS) and have undergone mechanical thrombectomy and intravenous thrombolytic therapy. The study focuses on patients with visible occlusive clots in specific brain arteries and aims to evaluate the Pulse NanoMED procedure to improve reperfusion after standard neurovascular treatment. Participants will receive the Pulse NanoMED System, which includes iron nanoparticles and a portable magnetic workstation, after attempted neurovascular therapy. This single-arm study enrolls subjects presenting with AIS and evidence of occlusive clots confirmed by angiographic imaging. The investigational device is applied post-thrombolytic therapy and mechanical thrombectomy to address residual occlusions. During the study, participants will be monitored at 24 hours, 7 days (or discharge if earlier), 30 days, and 90 days after the procedure. Researchers will assess clinical outcomes related to reperfusion and safety measures. The total involvement includes multiple follow-up visits to evaluate how well the treatment works and to monitor for any adverse effects.
CONDITIONS
Brief Title
Pulse Endovascular ReperFUSION for Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent or have an acceptable patient surrogate consent
- Be aged 18 years or older and younger than 85 years
- Have symptomatic large vessel occlusion treated with mechanical thrombectomy as standard care
- Have residual occlusion in anterior, middle, or posterior cerebral arteries with eTICI score >2b50 after mechanical thrombectomy with three or fewer device passes
- Estimated time for rescue device administration less than 9 hours from symptom onset
- Have had thrombolytic therapy within 9 hours prior to proposed device therapy
- No significant pre-stroke disability (modified Rankin scale 0-1)
- Baseline NIH Stroke Scale score 6 or higher
- ASPECTS score greater than 6 on non-contrast CT if symptoms lasted less than 8 hours
- Optional CT perfusion showing rCBF <30% lesion volume ≤70 mL, if performed
- Imaging obtained within 75 minutes of mechanical thrombectomy onset
You will not qualify if you...
- NIH Stroke Scale score on admission greater than 25
- Use of carotid artery stents requiring dual antiplatelet therapy
- Female who is pregnant, lactating, or has a positive pregnancy test at admission
- Participation in another investigational drug or device study
- Known allergy or sensitivity to iron
- Known bleeding disorders or coagulation factor deficiencies
- Coagulopathy with INR >1.7 or recent use of novel anticoagulants within 12 hours of symptom onset
- Platelet count less than 100,000
- Renal failure with serum creatinine >3.0 mg/dl or GFR <30
- Requires dialysis or has contraindications to angiogram
- Any hemorrhage seen on CT or MRI
- Suspected subarachnoid hemorrhage even if initial imaging is normal
- Suspicion of aortic dissection
- Current illicit drug use or alcohol abuse
- History of severe allergy to contrast medium
- Blood pressure above 185/110 mmHg not responsive to treatment
- Terminal illness with life expectancy less than 6 months
- Pre-existing neurological or psychiatric conditions that interfere with evaluation
- Presumed vasculitis or septic embolization
- Allergy to contrast materials that cannot be treated
- Use of Coumadin where interruption is unsafe
- Allergy or contraindication to double antiplatelet therapy
- Allergy or contraindication to iron or polyethylene glycol agents
- Contraindication to MRI (e.g., pacemaker, neurostimulator)
- Physical features preventing magnet placement
- Signs of systemic infection or sepsis unless localized and controlled
- Cardiovascular conditions causing heart block, tachycardia-bradycardia syndrome, or symptomatic hypotension needing treatment
- Suspected or known hemochromatosis or hemosiderosis
- Known liver disease such as hepatitis or cirrhosis
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 hours from symptom onset
Participants receive the Pulse NanoMED System device as part of their treatment following thrombolytic therapy and mechanical thrombectomy.
1 procedural visit (in-person)
Duration - 90 days
Participants are monitored for safety and treatment outcomes after the device implementation.
Visits at 24 hours, 7 days (or discharge if earlier), 30 days, and 90 days post-procedure
Trial Site Locations
Total: 1 location
1
University of South Carolina - Prisma
Columbia, South Carolina, United States, 29203
Actively Recruiting
Research Team
K
Kristen Hlozek, PhD
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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