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Procedure

Endovascular Reperfusion for Stroke (PERFUSION AIS Trial)

N/A

Recruiting

Research Sponsored by Euphrates Vascular, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Must not have

Known coagulopathy, INR >1.7, or use of novel anticoagulants <12h from symptom onset

Known hypersensitivity or contraindication to iron or polyethylene glycol-based agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial will study a medical procedure to improve stroke recovery in patients who had a thrombectomy.

Who is the study for?

This trial is for adults aged 18-85 who've had a stroke caused by a clot in major brain arteries and have already undergone mechanical thrombectomy. They must be within 9 hours of their last known well time, not severely disabled before the stroke, with certain scores on neurological and imaging assessments. Pregnant women, those with severe allergies to iron or contrast materials, serious coagulation disorders, uncontrolled high blood pressure, advanced terminal illnesses or conditions that interfere with the study can't participate.

What is being tested?

The Pulse NanoMED System is being tested in this early feasibility study to see if it can improve blood flow after standard treatment for acute ischemic stroke has left some blockage. Participants will receive this procedure at select U.S. centers following initial therapy like mechanical thrombectomy.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to the device's materials (like iron), issues from magnetic interactions due to its placement near the brain, and general risks associated with additional procedures post-stroke.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old.

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I had a clot removal procedure for a major brain artery blockage but still have some blockage.

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I can start treatment within 9 hours from when my symptoms first appeared.

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I was independent in daily activities before my stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder or my blood doesn't clot normally.

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I am allergic to iron or polyethylene glycol.

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I do not have any mental or nerve conditions that could affect study results.

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I am suspected to have inflammation of my blood vessels or infection-related blood clots.

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My kidney function is severely impaired.

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My symptoms suggest a brain bleed, even though my scans were normal.

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I might have a tear in the wall of my heart's main artery.

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My blood pressure remains high despite treatment.

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I take Coumadin and cannot safely stop it.

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I am allergic or cannot take certain blood thinning medications.

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I have a heart condition that affects my heart's rhythm or causes dizziness when standing up.

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I have or might have a condition causing too much iron in my body.

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I am not pregnant, breastfeeding, or have a positive pregnancy test.

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I have a known bleeding disorder.

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I need dialysis or cannot have an angiogram due to health reasons.

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I am on dual antiplatelet therapy due to carotid artery stents.

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I have or might have liver disease, like hepatitis or cirrhosis.

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My doctor expects I have less than 6 months to live due to my illness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours, 7 days (or discharge, if earlier), 30 days, and 90 days post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Objective

Secondary study objectives

Secondary Objective

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Group/CohortExperimental Treatment1 Intervention

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.

0 / 22Eligibility criteria met