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Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

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

NCT05755711•Shockwave Medical, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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 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

Key Dates

Start Date

May 3, 2023

Primary Completion Date

December 11, 2024

Completion Date

April 1, 2028

Last Updated

January 22, 2026

Enrollment

399

ACTUAL participants

Conditions

Coronary Artery Disease

Interventions

Shockwave Medical Coronary IVL System

DEVICE

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

NCT05681702

Coronary Artery Disease

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RECRUITING

"Erectile Function After PCI in MI and Non-MI Patients"

NCT07444697

Erectile DisfunctionCoronary Artery Disease (CAD)+3 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

"Erectile Function After PCI in MI and Non-MI Patients"

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

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