Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 2:58 PM
Study NCT ID:
NCT03814850
Status:
WITHDRAWN
Last Update Posted:
2023-12-08
First Post:
2019-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Ischemic PreConditioning (RIPC)
Sponsor:
Sebastian Koch
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants were identified per inclusion/exclusion criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 20180869 | OTHER | University of Miami IRB | View |