Acute Ischemic Stroke AISPERFUSION AISNCT06052969
Pulse Endovascular ReperFUSION for Acute Ischemic Stroke
A study testing Pulse NanoMED System in people with Acute Ischemic Stroke AIS and Cerebral Arterial Disease, run by Euphrates Vascular, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke AIS, Cerebral Arterial Disease
- What is being tested?
- Pulse NanoMED System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
- 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
- Known or suspected cardiovascular condition that causes a secondary or tertiary heart block, tachycardia-bradycardia syndrome, or symptomatic postural hypotension requiring medical intervention
- Known or suspected symptomatic hemochromatosis or hemosiderosis
- Known or suspected liver disease, such as hepatitis and/or cirrhosis
- The subject has received iron replacement therapy or contrast for iron-based MRI in the previous 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Carolina - Prisma
Columbia, South Carolina, 29203
Souvik Sen, MD, MS, MPH, 803-545-6073, souvik.sen@uscmed.sc.edu
Souvik Sen, MD, MS, MPH
About this study
Official title: PERFUSION AIS - Pulse Endovascular ReperFUSION for Acute Ischemic Stroke: An Early Feasibility Clinical Study
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.
- Being tested
- Pulse NanoMED System
- Keywords
- MicroBeads, Pulse NanoMed System
- Medical subject headings
- Cerebral Arterial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse NanoMED SystemDevice
The Pulse NanoMED System is comprised of iron nanoparticles and a small, portable, magnetic Workstation.
| Study group | Role | What they receive |
|---|---|---|
| Group/Cohort | Experimental | Subjects presenting to the emergency department with AIS, eligible for thrombolytic therapy, and with evidence of an occlusive clot by angiographic imaging will be considered for inclusion in the study. Post-thrombolytic therapy and mechanical thrombectomy eligible Subjects will receive the experimental NanoMED device. Receives: Device: Pulse NanoMED System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
To test the safety and feasibility of the Pulse NanoMED System in ischemic stroke patients. The potential clinical benefit of early recanalization will be visually assessed by a core laboratory by comparing baseline DSA, CTA, or MRA images with images taken at set timepoints.
Measured: 24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure
Secondary outcomes (1)
Secondary Objective
To test the hypothesis that ischemic stroke patients that receive thrombolytic therapy and endovascular therapy will have improved reperfusion as assessed by eTICI and clinical outcomes when provided adjunctive treatment with the Pulse NanoMED System.
Measured: 24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Oct 2023
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke AISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center, single-arm early feasibility study.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Euphrates Vascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052969
- Sponsor's protocol ID
- MED-CLN-001P
- Other IDs
- G220131/S001
- Acronym
- PERFUSION AIS
- Status last verified
- Aug 2025
- First submitted
- 11 Sep 2023
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERFUSION AIS - Pulse Endovascular ReperFUSION for Acute Ischemic Stroke: An Early Feasibility Clinical Study
- ClinicalTrials.gov ID
- NCT06052969
- Acronym / sponsor ID
- PERFUSION AIS / MED-CLN-001P
- Keywords
- MicroBeads, Pulse NanoMed System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Euphrates Vascular, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center, single-arm early feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Group/Cohort | Experimental | Device: Pulse NanoMED SystemSubjects presenting to the emergency department with AIS, eligible for thrombolytic therapy, and with evidence of an occlusive clot by angiographic imaging will be considered for inclusion in the study. Post-thrombolytic therapy and mechanical thrombectomy eligible Subjects will receive the experimental NanoMED device. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse NanoMED SystemThe Pulse NanoMED System is comprised of iron nanoparticles and a small, portable, magnetic Workstation. | Device | Group/Cohort |
Primary outcome
Primary Objective
Time frame: 24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure
To test the safety and feasibility of the Pulse NanoMED System in ischemic stroke patients. The potential clinical benefit of early recanalization will be visually assessed by a core laboratory by comparing baseline DSA, CTA, or MRA images with images taken at set timepoints.
1 secondary outcome
Secondary Objective
Time frame: 24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse NanoMED System in people with Acute Ischemic Stroke AIS and Cerebral Arterial Disease, run by Euphrates Vascular, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen Hlozek, PhD (857-334-0851, kristen@euphratesvascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.