Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT03361995
Status:
UNKNOWN
Last Update Posted:
2020-10-23
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)
Sponsor:
ZOLL Circulation, Inc., USA
Organization:
Study Overview
Official Title:
STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention In Patients With Acute Myocardial Infarction (Phase A)
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
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:
STEMI Cool
Brief Summary:
A Multicenter, Prospective, Randomized-Controlled Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention In Patients with Acute Myocardial Infarction. The Phase A portion of the trial will include 80 enrollments from up to 15 sites.
Detailed Description:
The overall objective of this randomized trial is to evaluate the Safety and Efficacy of intravascular cooling using the ZOLL Thermogard XP3 IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction and undergoing PCI.
The objective of the Phase A trial is to demonstrate successful incorporation of intravascular cooling into US standard of care.
The objective of the Phase A trial is to demonstrate successful incorporation of intravascular cooling into US standard of care.
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?: