At a glance
ClinicalIndex Comparison RecordN/ACompleted· 111 enrolled
Drug / intervention
Intravascular permissive hypothermia as an adjunct to PCIdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
COOL-AMI EU Pivotal Trial: A Multicenter, Prospective, Randomized-Controlled Trial to Assess the Safety and Effectiveness of Cooling As an Adjunctive Therapy to Percutaneous Intervention in Patients With Acute Myocardial Infarction
In Brief
A clinical study evaluating Intravascular permissive hypothermia as an adjunct to PCI for Acute Myocardial Infarction. Completed, enrolled 111 participants across 1 site.
Detailed Summary
The objective of this trial is to evaluate the safety and effectiveness of therapeutic hypothermia, using the ZOLL Proteus IVTM System, as an adjunctive therapy for patients presenting with acute anterior myocardial infarction (AMI) and undergoing percutaneous coronary intervention (PCI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myocardial Infarction
CountriesSlovenia
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
Enrollment StartApr 2017
First PostedJun 2017
Primary CompletionAug 2018
Study CompletionAug 2019
TodayJul 2026
First PostedJun 1, 2017
Enrollment StartApr 14, 2017
Primary CompletionAug 22, 2018
Study CompletionAug 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.1 years ago
Interventions
Intravascular permissive hypothermia as an adjunct to PCIdevice
Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI