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Ischemic Conditioning Device for Stroke (ICARUS Trial)

N/A

Recruiting

Led By Amir Shaban, MD

Research Sponsored by Amir Shaban

Eligibility Criteria Checklist

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

Must have

Patient screened for rtPA, and rtPA administered if eligible

Suspected acute ischemic stroke with symptoms suggestive of large vessel occlusion (aphasia, agnosia, neglect, visual field cut, and gaze preference)

Must not have

History of diabetes mellitus

Arteriovenous fistula in upper limb

Timeline

Screening 3 weeks

Treatment Varies

Follow Up aes will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether a device that temporarily cuts off blood flow to the limbs can help prevent damage from a stroke caused by a blockage in a large blood vessel.

Who is the study for?

This trial is for adults aged 18-80 who have had a stroke due to a blocked large vessel and show certain symptoms like speech difficulty or vision loss. They must be able to consent, not be in another study, not pregnant (women under 55 need a test), and without diabetes, limb injuries, or other specific vascular issues.

What is being tested?

The trial tests the Doctormate device on stroke patients during helicopter transport to see if it can protect brain tissue by temporarily restricting blood flow in a limb. The goal is to improve outcomes for those heading for clot removal procedures.

What are the potential side effects?

Possible side effects may include discomfort from the blood pressure cuff used by the Doctormate device and potential bruising or soreness in the limb where ischemic conditioning is applied.

Eligibility Criteria

Inclusion Criteria

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

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I was evaluated for and received rtPA treatment if I was eligible.

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I am experiencing symptoms like difficulty speaking or understanding, ignoring one side of my body, vision problems, or difficulty controlling my gaze, which may suggest a stroke.

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I am between 18 and 80 years old.

Exclusion Criteria

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

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I have diabetes.

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I have an abnormal connection between an artery and a vein in my arm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ aes will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~aes will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and aes will be assessed during transport by aircrew, at 24 hours of admission and at 90 days. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Evaluate the feasibility of delivering RLIC by air medical crews in patients with AIS. This will be assessed by recording the number of cycles completed during transport.

Secondary study objectives

Assess adverse events related to performing RLIC in patients with large vessel occlusion.