Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
NCT: NCT05755711 ·
Status: ACTIVE NOT RECRUITING ·
Phase: N/A
· Sponsor: Shockwave Medical, Inc.
· Started: 2023-05-03
· Est. Completion: 2028-04
Official 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.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 399 participants
Interventions
- DEVICE: Shockwave Medical Coronary IVL System — Coronary Intravascular Lithotripsy (IVL)
Primary Outcomes
- Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF) (within 30 days of index procedure)
- Primary Effectiveness Endpoint: Procedural Success (12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure)
Secondary Outcomes
- Angiographic Success (≤30% Residual Stenosis) (12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure)
- Procedural Success (12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure)
- Angiographic Success (< 50% Residual Stenosis) (12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure)
- Serious Angiographic Complications (12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure)
- Target Lesion Failure (TLF)-1 Year (1 year post procedure)
Trial Locations
- 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
- ...and 10 more locations
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.