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

Running, not enrolling

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT05755711

Run by

Shockwave Medical, Inc.

People needed

399

Starts

2023-05-03

Expected to finish

2028-04-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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