NCT03481205

Ischemic Conditioning During Air tRansport Save penUmbral Tissue

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Enrique Leira · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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)

Conditions

• Acute Stroke

Interventions

Type	Name	Description
DEVICE	Ischemic conditioning device	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.

Timeline

• Start date: 2020-06-01
• Primary completion: 2026-12-01
• Completion: 2026-12-31
• First posted: 2018-03-29
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study