STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myocardial Infarction
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03361995
- Collaborators
- Not Provided
- Investigators
- Not Provided