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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Cooling Procedure with ZOLL Thermogard XP3 IVTM System before and after Percutaneous Coronary Intervention (PCI)
Standard of Care for PCI
Phase A Safety Endpoint: Incidence of MACE at 30 days.
MACE is defined as Subjects who experienced any of the following events: * All-cause death (cardiac, vascular, non-cardiovascular) * Myocardial infarction (MI) * Clinically-indicated target vessel revascularization (CI TVR) * Definite or probable stent thrombosis (ST) * New or worsening heart failure (HF) after 24 hours from the end of index PCI, or subsequent re-hospitalization for HF * Stroke * Major bleeding
Time frame: Through study completion, approximately 1 year
Phase A Device Performance Endpoint: Proportion of cooled patients who reach ≤34° at PCI.
Time frame: Through study completion, approximately 1 year
Phase A Secondary Safety Endpoint 1: Proportion of patients reaching <90 min door-to-balloon time.
The performance goal is at least 93.5% of the patients in Phase A, with Test and Control arms evaluated separately.
Time frame: Through study completion, approximately 1 year
Phase A Secondary Safety Endpoint 2: Rate of a composite safety endpoint at 30 days.
Rate of a composite safety endpoint at 30 days defined as the following: * Cardiovascular death * Myocardial infarction (MI) * Clinically-indicated target vessel revascularization (CI TVR) * Definite or probable stent thrombosis (ST) * New or worsening heart failure (HF) after 24 hours from the end of index PCI, or subsequent re-hospitalization for HF * Stroke * Major bleeding
Time frame: Through study completion, approximately 1 year
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