Acute StrokeICARUSNCT03481205
Ischemic Conditioning During Air tRansport Save penUmbral Tissue
A study testing Ischemic conditioning device in people with Acute Stroke, run by Enrique Leira at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device used to perform RLIC, on patients with acute ischemic stroke due to large vessel occlusion being transported to a thrombectomy capable center… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Ischemic conditioning device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤ 80 years
- Suspected acute ischemic stroke with symptoms suggestive of large vessel occlusion (aphasia, agnosia, neglect, visual field cut, and gaze preference).
- Patient screened for rtPA, and rtPA administered if eligible
- Subject or legally authorized representative able to provide consent at the time of the assessment
- NIHSS 6-20
Who cannot join
- Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) on CT scan at the community hospital
- History of upper or lower extremity ischemia, known subclavian, brachial artery, iliac or femoral artery stenosis, subclavian steal syndrome, any upper or lower extremity soft tissue, orthopedic or vascular injury, or mastectomy or other procedure that may contraindicate taking blood pressure or having a cuff on the arm or leg for the conditioning treatment
- History of diabetes mellitus
- Enrollment in another clinical trial
- Patient incarcerated
- Pregnancy. Patients ages 18-55 will need to have a negative urine or blood based pregnancy test.
- Agitation deemed unsafe for ischemic preconditioning testing.
- Arteriovenous fistula in upper limb
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 Iowa
Iowa City, Iowa, 52242
Enrique Leira, MD
About this study
The purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device used to perform RLIC, on patients with acute ischemic stroke due to large vessel occlusion being transported to a thrombectomy capable center by the helicopter.
Read the detailed description
In this study, 15 subjects presenting to a community hospital with signs and symptoms of ischemic stroke due to large vessel occlusion, transported to a comprehensive stroke center by aircew will receive RLIC using the Doctormate device.
The RLIC treatment will consist of 3-5 cycles ( depending on transportation time) of 5 minutes inflations of both blood pressure cuffs simultaneously. Blood pressure will be 200 mm HG with 5 minutes of reperfusion between each inflation.
Subjects will be evaluated upon arrival to the comprehensive stroke center and evaluated for side effects.
The study will be conducted at one site ( University of Iowa Hospitals and Clinics)
- Conditions
- Acute Stroke
- Being tested
- Ischemic conditioning device
- Keywords
- remote limb ischemic conditioning, large vessel occlusion, helicopter transport
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic conditioning deviceDevice
Also called Standard medical care
RLIC will be done using a specialized blood pressure device ( Doctormate) that inflates to 200 mm HG for 5 minutes followed by 5 minutes deflation.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Conditioning | Experimental | Doctormate device used en route to the comprehensive stroke center Receives: Device: Ischemic conditioning device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Feasibility will be assessed based on the number of cycles performed during transportation by air as follows:
For flight time of duration of ≥ 60 minutes, ≥ 60% of subjects should receive 4 cycles of RLIC.
For flight time of duration of 30-60 minutes, ≥ 60% of subjects should receive at least 3 cycles of RLIC.
For flight duration of < 30 minutes, ≥60% of subjects should receive at least 2 cycle of RLIC.
Measured: The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital
Secondary outcomes (1)
Assess adverse events related to performing RLIC in patients with large vessel occlusion.
We will collect data on adverse events, severe and serious adverse events during transport, at 24 hours of hospital admission as well as at the 3 months follow up visit. An intendent medical monitor will be designated to evaluate the reported serious and related adverse events
Measured: AEs will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Jun 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enrique Leira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enrique Leira, University of Iowa
- Investigators
- Enrique Leira, MD, Principal investigator, University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481205
- Sponsor's protocol ID
- 201712791
- Acronym
- ICARUS
- Status last verified
- Nov 2025
- First submitted
- 13 Mar 2018
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Conditioning During Air tRansport Save penUmbral Tissue
- ClinicalTrials.gov ID
- NCT03481205
- Acronym / sponsor ID
- ICARUS / 201712791
- Conditions
- Acute Stroke
- Keywords
- remote limb ischemic conditioning, large vessel occlusion, helicopter transport
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Enrique LeiraUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Mar 2018 (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.
The purpose of this study is to demonstrate the feasibility of performing remote limb ischemic conditioning (RLIC) using the Doctormate device, a special blood pressure device used to perform RLIC, on patients with acute ischemic stroke due to large vessel occlusion being transported to a thrombectomy capable center by the helicopter.
Detailed description
In this study, 15 subjects presenting to a community hospital with signs and symptoms of ischemic stroke due to large vessel occlusion, transported to a comprehensive stroke center by aircew will receive RLIC using the Doctormate device.
The RLIC treatment will consist of 3-5 cycles ( depending on transportation time) of 5 minutes inflations of both blood pressure cuffs simultaneously. Blood pressure will be 200 mm HG with 5 minutes of reperfusion between each inflation.
Subjects will be evaluated upon arrival to the comprehensive stroke center and evaluated for side effects.
The study will be conducted at one site ( University of Iowa Hospitals and Clinics)
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic Conditioning | Experimental | Device: Ischemic conditioning deviceDoctormate device used en route to the comprehensive stroke center |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 and ≤ 80 years
- Suspected acute ischemic stroke with symptoms suggestive of large vessel occlusion (aphasia, agnosia, neglect, visual field cut, and gaze preference).
- Patient screened for rtPA, and rtPA administered if eligible
- Subject or legally authorized representative able to provide consent at the time of the assessment
- NIHSS 6-20
Key exclusion criteria (8 listed)
- Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) on CT scan at the community hospital
- History of upper or lower extremity ischemia, known subclavian, brachial artery, iliac or femoral artery stenosis, subclavian steal syndrome, any upper or lower extremity soft tissue, orthopedic or vascular injury, or mastectomy or other procedure that may contraindicate taking blood pressure or having a cuff on the arm or leg for the conditioning treatment
- History of diabetes mellitus
- Enrollment in another clinical trial
- Patient incarcerated
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 |
|---|---|---|
| Ischemic conditioning deviceAlso: Standard medical careRLIC will be done using a specialized blood pressure device ( Doctormate) that inflates to 200 mm HG for 5 minutes followed by 5 minutes deflation. | Device | Ischemic Conditioning |
Primary outcome
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.
Time frame: The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital
Feasibility will be assessed based on the number of cycles performed during transportation by air as follows: For flight time of duration of ≥ 60 minutes, ≥ 60% of subjects should receive 4 cycles of RLIC. For flight time of duration of 30-60 minutes, ≥ 60% of subjects should receive at least 3 cycles of RLIC. For flight duration of < 30 minutes, ≥60% of subjects should receive at least 2 cycle of RLIC.
1 secondary outcome
Assess adverse events related to performing RLIC in patients with large vessel occlusion.
Time frame: AEs will be assessed during transport by aircrew, at 24 hours of admission and at 90 days.
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 10 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Enrique Leira, MD principal investigator
University of Iowa Hospitals and Clinics- 200 Hawkins Dr, Iowa City, IA 52242
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic conditioning device in people with Acute Stroke, run by Enrique Leira 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 5 inclusion and 8 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 10 Nov 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 Amir Shaban, MD (3193568755, amir-shaban@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: The duration of the flight, typically 30 min-3 hours depending on weather and distance of the community hospital). 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 10 Nov 2025.