EMPOWER CAD: Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Female subjects referred for percutaneous coronary intervention Female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care. |
Device: Shockwave Medical Coronary IVL System
Coronary Intravascular Lithotripsy (IVL)
|
Outcome Measures
Primary Outcome Measures
- Primary Safety Endpoint [30 days]
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).
- Primary Effectiveness Endpoint [12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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The subject is a non-pregnant female ≥18 years of age
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The subject meets indications for PCI and stent
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The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion
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The subject is willing to comply with protocol-specified follow-up evaluations
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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:
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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
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Subjects presenting with cardiogenic shock at the time of the index procedure
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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
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Subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines
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Subject is enrolled in any study of an investigational device or drug that may interfere with study results
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shockwave Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP 67712