Protect Kidney Trial

Exclusion Criteria

• •1. Previous participation in this trial. Participation is defined as randomized.
• •2. Patients with contraindications to use of an Impella heart pump (mural thrombus in the left ventricle; presence of a mechanical aortic valve or aortic valve stenosis (equivalent orifice area of 1.5 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); in whom severe peripheral arterial disease precluding placement of an Impella system)
• •3. Patients where hemodynamic support is deemed potentially required for PCI as assessed by at least one physician
• •4. Patients needing emergency percutaneous coronary intervention (e.g. STEMI patients)
• •5. Patients with acute cardiogenic shock indicated by one of the following:
• •1. Systolic blood pressure \< 90mmHg over 30 minutes or inotropic support needed to maintain blood pressure targets.
• •2. Killip class III \& IV
• •3. MCS already in place to maintain blood pressure and organ perfusion
• •6. Patients with on-going resuscitation
• •7. Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to screening OR any impairment in mental status, cognition, or any global or focal neurological deficit
• •8. Patients on mechanical ventilation.
• •9. Patients diagnosed with AKI within the last seven days prior to screening or incipient AKI. (In cases, where AKI cannot be ruled out as a cause for elevated serum creatine, a rise or fall above 30% of a second serum creatinine measurement obtained within 12 to 24 hours is indicative of AKI)
• •10. Patients with an eGFR \< 20 ml/min/1.73 m²
• •11. Suspected or known pregnancy
• •12. Patients with comorbidity that in the Investigator's opinion would limit life expectancy to less than 6 months
• •13. Patients with other medical, social, or psychological problems that, in the opinion of the Investigator, preclude them from undergoing Impella-protected PCI or the study-related procedures, evaluations, and follow-up.
• •14. Patients with severe anemia as indicated by hemoglobin concentrations \< 8.5 g/dl at the time of screening.
• •15. Patients who were exposed to contrast media in the last seven days prior to the time of screening
• •16. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• •17. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary end point.
• •Patients with contraindications against MRI-procedures (e.g. patients with pacemakers) are eligible for the study but will not participate in the BOLD-MRI assessment.