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

Study Overview
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Brief Summary
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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.

Detailed Description
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Subject population: up to 400 female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care at up to 50 global sites in the US, UK and Europe. Subjects will have clinical follow-up prior to discharge from the index intervention and at 30 days, 1, 2 and 3 years.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Shockwave Medical Coronary IVL System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is a non-pregnant female ≥18 years of age The subject meets indications for PCI and stent The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion The subject is willing to comply with protocol-specified follow-up evaluations The 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 year Subjects presenting with cardiogenic shock at the time of the index procedure Serious 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 reflow Subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines Subject is enrolled in any study of an investigational device or drug that may interfere with study results

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Female subjects referred for percutaneous coronary intervention<br>Female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care. | Device: Shockwave Medical Coronary IVL System<br>* Coronary Intravascular Lithotripsy (IVL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Target lesion failure (TLF) at 30 days defined as a composite of cardiac death, myocardial infarction (per SCAI definition for peri-procedural MI; per 4th Universal Definition for spontaneous MI beyond discharge) attributable to target vessel (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR). | 30 days | 
| Primary Effectiveness Endpoint | Procedural Success defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions (core laboratory assessed) and without in-hospital TLF (CEC adjudicated). | 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravascular Lithotripsy, Percutaneous Coronary Intervention