coronair sclerose
Conditions
Interventions
prior to or during the treatment, the pulscath iVAC2L heart pump will be
inserted according to standard hospital prescription
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Indicated for High-Risk PCI, according to hospital standard procedure * Indicated to have an IABP during the PCI, according to hospital standard procedure * Expected duration of iVAC2L support: maximum 24 hours * Patient older than 18 years * Patient has signed the Informed Consent
Exclusion criteria
Exclusion criteria: * Aortic disease: ascending aortic aneurism, severe calcified aorta * Aortic valvular disease: severe aortic valve stenosis, severe aortic valve insufficiency * Aortic mechanical valve prosthesis * Thrombus in left ventricle * Intra ventricular septum defect * Severe peripheral vascular disease * No functioning right ventricle * History of coagulation disorders * Participation in another clinical study that may interfere with this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The application of the device is considered safe when: 1) MACE 2.5 L/min/m2; Mean Arterial Pressure > 60 mmHg, during the whole duration of support by the iVAC2L Clinical success is achieved when the patient has successfully been weaned from the device. | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed