Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
NCT ID: NCT05755711
Last Updated: 2026-01-22
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
399 participants
OBSERVATIONAL
2023-05-03
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Female subjects referred for percutaneous coronary intervention
Female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care.
Shockwave Medical Coronary IVL System
Coronary Intravascular Lithotripsy (IVL)
Interventions
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Shockwave Medical Coronary IVL System
Coronary Intravascular Lithotripsy (IVL)
Eligibility Criteria
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Inclusion Criteria
2. The subject meets indications for PCI and stent
3. The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion
4. The subject is willing to comply with protocol-specified follow-up evaluations
5. 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
2. Subjects presenting with cardiogenic shock at the time of the index procedure
3. 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
4. Subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines
5. Subject is enrolled in any study of an investigational device or drug that may interfere with study results
18 Years
FEMALE
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Northside Hospital
Atlanta, Georgia, United States
Northwestern University
Evanston, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tulane University Center for Clinical Research
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
New England Heart and Vascular Institute
Manchester, New Hampshire, United States
NYU Langone Health
Brooklyn, New York, United States
NYU Langone Health
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Lindner Center for Research and Education at The Christ Hospital CRA: Timothy
Cincinnati, Ohio, United States
WellSpan York Hospital
York, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
MUSC Health University Medical Center
Charleston, South Carolina, United States
Centennial Heart
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
DHR Health Heart Institute
McAllen, Texas, United States
Baylor Scott & White Research Institute
Plano, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Overlake Medical Center
Bellevue, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Centre Hospitalier d'Antibes
Antibes, Antibes, France
Clinique Pasteur
Toulouse, BP 27617, France
AP-HP Hopital Pitie-Salpetriere
Paris, Paris, France
Institut Cardiovasculaire Paris Sud Hôpital Privé Jacques Cartier
Massy, , France
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
Mainz, Langenbeckstr. 1, Germany
Krankenhaus der Barmherzigen Bruder Trier
Trier, Nordallee 1, Germany
Heart and Lung Center Leipzig
Leipzig, , Germany
Hospital Clinico De Santiago
Santiago de Compostela, A Coruña, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Golden Jubilee National Hospital
Clydebank, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
St. George's Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP 67712
Identifier Type: -
Identifier Source: org_study_id
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