CIP Pulsecath iVAC2L in High-Risk PCI patients
Completed
- Conditions
- coronair sclerose100110821000318410057166
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The application of the device is considered safe when:<br /><br>1) MACE < 20%<br /><br>2) the degree of hemolysis was manageable<br /><br>The efficacy of the device is considered established when:<br /><br>1) the surgical introduction, positioning, fixation and removal of the iVAC2L<br /><br>has been<br /><br>performed without any injury of valvular or vascular structures, and the device<br /><br>has not<br /><br>caused perfusion disorders of the peripheral arteries<br /><br>2) the hemodynamic parameters could be maintained according to the following<br /><br>limits:<br /><br>Cardiac Index > 2.5 L/min/m2; Mean Arterial Pressure > 60 mmHg, during the whole<br /><br>duration of support by the iVAC2L<br /><br>Clinical success is achieved when the patient has successfully been weaned from<br /><br>the<br /><br>device.</p><br>
- Secondary Outcome Measures
Name Time Method <p>N.A.</p><br>