Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-04 @ 9:47 PM
Study NCT ID:
NCT03481205
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2018-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ischemic Conditioning During Air tRansport Save penUmbral Tissue
Sponsor:
Enrique Leira
Organization:
Study Overview
Official Title:
Ischemic Conditioning During Air tRansport Save penUmbral Tissue
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICARUS
Brief 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 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)
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: