NCT03814850

Remote Ischemic PreConditioning (RIPC)

Remote Ischemic PreConditioning Provides Neuroprotection: A Phase 2, Single Center, Randomized, Double-Blind, Sham-Controlled, Safety and Efficacy Study Evaluating the Use of Remote Ischemic Preconditioning in Patients Undergoing Endovascular Repair of Brain Aneurysms

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sebastian Koch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn about protecting the brain from low blood flow (ischemia) with limb preconditioning. From human studies the investigators know that the brain can be protected from dangerous low blood flow by reducing the blood flow to an arm or leg for just a short period of time. This is called limb preconditioning. The investigators are studying the safety and feasibility of preconditioning and their effect of protecting the brain from ischemia in two different groups. This is a Phase 2, randomized, double-blind, sham-controlled, design. Up to 50 male and female patients undergoing elective endovascular repair of unruptured brain aneurysm who are randomized to the remote ischemic preconditioned or sham group will be enrolled. This study consists of one 3-9 month study period for each patient plus up to 14 days for enrollment activities. Subjects are required to return between 3-9 months for end-of-study procedures.

Conditions

• Unruptured Cerebral Aneurysm

Interventions

Type	Name	Description
DEVICE	Standard Manual Aneroid Sphygmomanometer	Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-01-24
• Last updated: 2023-12-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study