stent placement
Conditions
Interventions
use of PHP device during elective high risk PCI
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * At least 18 years of age. * Patient presents with a non-emergent need for complex PCI and in the opinion of the investigator is a risk of hemodynamic compromise during PCI. * Written, signed, and dated informed consent
Exclusion criteria
Exclusion criteria: *Emergent PCI *ST elevation myocardial infarction within 7 days of procedure *Cardiac arrest within 7 days of procedure requiring CPR or defibrillation *Hemodynamic support with the HeartMate PHP post-PCI is anticipated *Cardiogenic shock (SBP 1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index 3.5mg/dL within 7 days of procedure *Liver dysfunction with elevation of liver enzymes and bilirubin levels to * 3x ULN or INR (Internationalized Normalized Ratio) *2 *Uncorrectable abnormal coagulation parameters *Active systemic infection requiring treatment with antibiotics *Clinically relevant stroke or TIA within 3 months of procedure. Patients with suspected stroke or TIA within 3 months of procedure must have documented absence of neurological infarction *Uncontrollable allergy or intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs *History of heparin induced thrombocytopenia *Patient is pregnant or planning to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Performance Evaluation: Safety Endpoints: Outcomes and Adverse Events * Death (including cardiac Death) * Myocardial infarction ** Surgical intervention due to device complication or malfunction ** Device-related access site complication requiring intervention or device-related limb ischemia ** Cerebral vascular accident (CVA) ** New or worsening aortic valve insufficiency ** Major bleeding complication (BARC 3 or 5) Performance endpoints: * Change in Mean Arterial Pressure from baseline (MAP * Maximal decrease in cardiac power output (CPO) from baseline * Changes in central venous pressure from baseline (CVP) * Changes in pulmonary artery pressure from baseline (PAP) * Changes in pulmonary capillary wedge pressure from baseline (PCWP) * Changes in cardiac output from baseline (CO) * Changes in cardiac index from baseline (CI) | — |
Countries
Netherlands
Outcome results
None listed