Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT05755711
- Lead Sponsor
- Shockwave Medical, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 399
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
Loma Linda University Health
🇺🇸Loma Linda, California, United States
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Kaiser Permanente - San Francisco Medical Center
🇺🇸San Francisco, California, United States
Stanford University
🇺🇸Stanford, California, United States
South Denver Cardiology Associates, P.C
🇺🇸Littleton, Colorado, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Emory Hospital
🇺🇸Atlanta, Georgia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
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