Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (Shield II)
DescriptionProspective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 100 sites in the US. Control device will be any Abiomed Impella device approved for use in high-risk PCI. Nonrandomized roll-in phase: Each site must first enroll and treat up to 6 patients (up to 3 PHP and 3 Impella per site) Randomized phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.
Inclusion and Exclusion Criteria
- At least 18 years of age
- Patient is undergoing elective or urgent high risk PCI procedure and is hemodynamically stable
- Patient is indicated for a revascularization of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
- A heart team, including a cardiac surgeon, has determined high risk PCI is an acceptable therapeutic option
- The presence of complex coronary artery disease (CAD) makes hemodynamic instability resulting from repeat episodes of reversible myocardial ischemia during PCI likely. Complex CAD is defined as: o an ejection fraction of ≤35% AND at least one of the following:
- intervention of the last patent coronary conduit, OR
- intervention of an unprotected left main artery, OR
- intervention on patient presenting with triple vessel disease defined as at least one significant stenosis (at least 50% diameter stenosis on visual assessment) in all three major epicardial territories
- Written, signed, and dated informed consent
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.