NL-OMON53537
Not Yet Recruiting
N/A
Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial - The PROTECT IV Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease - narrowing/hardening of arteries that supply the heart with blood
- Sponsor
- Abiomed, Inc.
- Enrollment
- 50
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •Subjects must meet all of the following Inclusion Criteria to participate in
- •1\. Age \>\=18 years and \<\=90 years
- •2\. Clinical presentation and baseline left ventricular function are as follows:
- •Either 2A or 2B must be present
- •A. Subject has CCS or NSTEMI with an LVEF \<\=40%
- •NOTE: The LVEF must be quantitatively measured as \<\=40% by echo within 30 days
- •assuming no change in clinical condition. If multiple echos have been performed
- •within 30 days, the most recent test must be used to qualify the patient. NOTE:
- •Subject qualifies if the quantitative site read LVEF is \<\=30%; if the
Exclusion Criteria
- •Exclusion Criteria:
- •Subjects must NOT meet any of the following Exclusion Criteria to participate
- •in the Trial
- •1\. STEMI \<\=24 hours from the onset of ischemic symptoms or at any time if
- •mechanical complications of transmural infarction are present (e.g., VSD,
- •papillary muscle rupture, etc.)
- •2\. Cardiogenic shock (SBP \<80 mmHg for \>\=30 mins and not responsive to
- •intravenous fluids or hemodynamic deterioration for any duration requiring
- •pressors or mechanical circulatory support, including IABP)
- •3\. Subject is presently or recently intubated for the current admission (NOTE:
Outcomes
Primary Outcomes
Not specified
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