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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.

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

PERFUSION AIS Trial 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.Check my eligibility

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.See study design

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.

PERFUSION AIS Trial 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.

PERFUSION AIS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Objective

Secondary outcome measures

Secondary Objective

PERFUSION AIS 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Euphrates Vascular, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must prospective participants fulfill in order to be eligible for this trial?

"For this clinical trial, 8 individuals with cerebral artery disease and between 18-85 years of age are being admitted. Selected patients must meet the following criteria: They have to possess an ASPECTS rating higher than 6 on a NCCT scan when symptoms last for less than eight hours; they need to provide written consent via approved Informed Consent Forms (ICFs); their estimated delay from symptom onset to rescue Pulse NanoMED MicroBead administration is lower than 9 hours since their “last known well” point in time; thrombolytic therapy was administered less than 9 hours prior to the proposed start time of System therapy"

Answered by AI

Does this investigation accept individuals older than 35 years of age?

"To be eligible for this medical study, patients need to fall within the age range of 18-85. There are 66 studies pertinent to participants under 18 and 1351 trials that apply to those over 65."

Answered by AI

How many individuals have been selected to participate in this research?

"Affirmative. On clinicaltrials.gov, it is evident that enrollment for this medical trial opened on October 1st 2023 and was recently updated on the 2nd of the same month. 8 volunteers are needed from one location to complete the study."

Answered by AI

Is this experiment in need of additional participants?

"Affirmative. Clinicaltrials.gov documents that this clinical trial, which was initially unveiled on October 1st 2023, is presently enrolling patients. A total of 8 individuals must be recruited from a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pulse Endovascular ReperFUSION for Acute Ischemic Stroke

2023. "Pulse Endovascular ReperFUSION for Acute Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052969.

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