Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease

Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.

Inclusion Criteria:The subject is a non-pregnant female ≥18 years of ageThe subject meets indications for PCI and stentThe subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesionThe subject is willing to comply with protocol-specified follow-up evaluationsThe subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)Exclusion Criteria:Subjects with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one yearSubjects presenting with cardiogenic shock at the time of the index procedureSerious angiographic complication in the target vessel prior to treatment with coronary IVL including-severe dissection (Type D to F), perforation, abrupt closure, persistent slow-flow or persistent no reflowSubject unable to tolerate anticoagulation/antiplatelet therapy per guidelinesSubject is enrolled in any study of an investigational device or drug that may interfere with study results