Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876040
Status:
WITHDRAWN
Last Update Posted:
2024-01-24
First Post:
2021-05-03
Brief Title:
Incorporating Supersaturated Oxygen in Shock
Sponsor:
TherOx
Organization:
TherOx
Study Overview
Official Title:
A Multi-Center Randomized-Controlled Trial To Evaluate The Safety And Feasibility of The Delivery Of Intracoronary Hyperoxemic Supersaturated Oxygen Therapy For 60 Minutes In Patients With St Elevation Myocardial Infarction STEMI And Cardiogenic Shock After Successful Reperfusion Via PCI Six Hours After Symptom Onset Compared To Standard Therapy
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISO-SHOCK
Brief Summary:
A multi-center prospective randomized 11 pilot and feasibility study to evaluate the safety and feasibility of supersaturated oxygen SSO2 therapy delivered for 60 minutes selectively into the culprit coronary artery of patients presenting with ST elevation myocardial infarction and cardiogenic shock STEMI-CS treated using a shock protocol
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None