Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-06 @ 9:04 AM
Study NCT ID:
NCT03804060
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2019-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REperfusion With Cooling in CerebraL Acute IscheMia II
Sponsor:
ZOLL Circulation, Inc., USA
Organization:
Study Overview
Official Title:
A Multicenter, Prospective, Randomized-controlled Trial to Assess the Safety and Feasibility of Cooling as an Adjunctive Therapy to Thrombectomy and Reperfusion in Patients With Acute Cerebral Ischemia and Stroke
Status:
COMPLETED
Status Verified Date:
2024-05
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:
RECCLAIM-II
Brief Summary:
The primary objective of this study is to determine the feasibility and safety of achieving rapid hypothermia with the Proteus Intravascular Temperature Management (IVTM) system for patients experiencing acute ischemic stroke due to a large vessel occlusion.
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?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: