NCT03361995

STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to PCI In Patients With Acute MI (Phase A)

STEMI Cool Pilot Trial to Assess Cooling as an Adjunctive Therapy to Percutaneous Intervention In Patients With Acute Myocardial Infarction (Phase A)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ZOLL Circulation, Inc., USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Cooling Procedure using the ZOLL Thermogard XP3 IVTM System	Cooling Procedure with ZOLL Thermogard XP3 IVTM System before and after Percutaneous Coronary Intervention (PCI)
DEVICE	PCI	Standard of Care for PCI

Timeline

• Start date: 2020-02-20
• Primary completion: 2022-05-12
• Completion: 2022-05-12
• First posted: 2017-12-05
• Last updated: 2026-04-15

Regulatory

• FDA-regulated device study