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

NCT05755711 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: CP 67712
• Study Type: observational
• Target: 399
• Locations: 5 countries
• Sites: 49

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Intravascular Lithotripsy; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF)

  Target lesion failure (TLF) at 30 days defined as a composite of cardiac death, myocardial infarction (per SCAI definition for peri-procedural MI; per 4th Universal Definition for spontaneous MI beyond discharge) attributable to target vessel (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR).

  within 30 days of index procedure

• Primary Effectiveness Endpoint: Procedural Success

  Procedural Success defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions (core laboratory assessed) and without in-hospital TLF (CEC adjudicated).

  12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure

Secondary Outcomes (33)

• 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

Study Arms (1)

Female subjects referred for percutaneous coronary intervention

Female subjects referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care.

Device: Shockwave Medical Coronary IVL System

Interventions

Shockwave Medical Coronary IVL System DEVICE

Coronary Intravascular Lithotripsy (IVL)

Female subjects referred for percutaneous coronary intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The subject is a non-pregnant female ≥18 years of age, (female sex assigned at birth)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care.

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

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (49)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

Kaiser Permanente - San Francisco Medical Center

San Francisco, California, 94118, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

South Denver Cardiology Associates, P.C

Littleton, Colorado, 80120, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Emory Hospital

Atlanta, Georgia, 30308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Tulane University Center for Clinical Research

New Orleans, Louisiana, 70112, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

New England Heart and Vascular Institute

Manchester, New Hampshire, 03102, United States

Location

NYU Langone Health

Brooklyn, New York, 11220, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The Lindner Center for Research and Education at The Christ Hospital CRA: Timothy

Cincinnati, Ohio, 45219, United States

Location

WellSpan York Hospital

York, Pennsylvania, 17403, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MUSC Health University Medical Center

Charleston, South Carolina, 29425, United States

Location

Centennial Heart

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

DHR Health Heart Institute

McAllen, Texas, 78503, United States

Location

Baylor Scott & White Research Institute

Plano, Texas, 75093, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Overlake Medical Center

Bellevue, Washington, 98004, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Centre Hospitalier d'Antibes

Antibes, Antibes, 06606, France

Location

Clinique Pasteur

Toulouse, BP 27617, 31076 Cedex 3, France

Location

AP-HP Hopital Pitie-Salpetriere

Paris, Paris, 75013, France

Location

Institut Cardiovasculaire Paris Sud Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

Mainz, Langenbeckstr. 1, 55131, Germany

Location

Krankenhaus der Barmherzigen Bruder Trier

Trier, Nordallee 1, 54292, Germany

Location

Heart and Lung Center Leipzig

Leipzig, Germany

Location

Hospital Clinico De Santiago

Santiago de Compostela, A Coruña, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Golden Jubilee National Hospital

Clydebank, G81 4HX, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

St. George's Hospital

London, SW17 0QT, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS,, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

The study is a post-market observational study.

Results Point of Contact

• Title: Tracy Courtney
• Organization: Shockwave Medical

TCourtn4@its.jnj.com

1.650.224.7699

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 6, 2023
• Study Start: May 3, 2023
• Primary Completion: December 11, 2024
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 27, 2026
• Results First Posted: January 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (34); ES (4); GB (4); FR (4); DE (3)