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

Active Not RecruitingN/A

Sponsor: Shockwave Medical, Inc.

Conditions: Coronary Artery Disease

Interventions: Shockwave Medical Coronary IVL System

Countries: United States, France, Germany, Spain, United Kingdom

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. The subject is a non-pregnant female ≥18 years of age
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:

1. 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
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

Locations (49)

Loma Linda, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Stanford, California, United States
Littleton, Colorado, United States
New Haven, Connecticut, United States
Clearwater, Florida, United States
Tallahassee, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Evanston, Illinois, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Manchester, New Hampshire, United States
Brooklyn, New York, United States
New York, New York, United States
New York, New York, United States
Roslyn, New York, United States
The Bronx, New York, United States
Cincinnati, Ohio, United States
York, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
McAllen, Texas, United States
Plano, Texas, United States
+ 19 more on CT.gov