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Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (Shield II)

Description

Prospective, 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.

Phase

N/A

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

    Sites

    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.

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