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

NCT05755711 · tracked via the Priya Life Science USA tracker

Sponsor

Shockwave Medical, Inc.

Phase

Observational

Started

2023-05-03

Last updated

2026-07-30

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Shockwave Medical Coronary IVL System

Shockwave Medical Coronary IVL System: Coronary Intravascular Lithotripsy (IVL)

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF) — within 30 days of index procedure
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).
Primary Effectiveness Endpoint: Procedural Success — 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
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).

Trial sites (49)

Facility	City	Region
Loma Linda University Health	Loma Linda	California
Good Samaritan Hospital	Los Angeles	California
Kaiser Permanente - San Francisco Medical Center	San Francisco	California
Stanford University	Stanford	California
South Denver Cardiology Associates, P.C	Littleton	Colorado
Yale New Haven Hospital	New Haven	Connecticut
Morton Plant Hospital	Clearwater	Florida
Tallahassee Research Institute	Tallahassee	Florida
Emory Hospital	Atlanta	Georgia
Piedmont Heart Institute	Atlanta	Georgia
Northside Hospital	Atlanta	Georgia
Northwestern University	Evanston	Illinois
University of Kansas Medical Center	Kansas City	Kansas
Tulane University Center for Clinical Research	New Orleans	Louisiana
Massachusetts General Hospital	Boston	Massachusetts
Brigham and Women's Hospital	Boston	Massachusetts
New England Heart and Vascular Institute	Manchester	New Hampshire
NYU Langone Health	Brooklyn	New York
NYU Langone Health	New York	New York
Columbia University Medical Center	New York	New York
St. Francis Hospital	Roslyn	New York
Montefiore Medical Center	The Bronx	New York
The Lindner Center for Research and Education at The Christ Hospital CRA: Timothy	Cincinnati	Ohio
WellSpan York Hospital	York	Pennsylvania
Rhode Island Hospital	Providence	Rhode Island
MUSC Health University Medical Center	Charleston	South Carolina
Centennial Heart	Nashville	Tennessee
Vanderbilt University Medical Center	Nashville	Tennessee
DHR Health Heart Institute	McAllen	Texas
Baylor Scott & White Research Institute	Plano	Texas
University of Texas Health Science Center at San Antonio	San Antonio	Texas
Inova Fairfax Medical Campus	Falls Church	Virginia
Overlake Medical Center	Bellevue	Washington
University of Washington Medical Center	Seattle	Washington
Centre Hospitalier d'Antibes	Antibes	Antibes
Clinique Pasteur	Toulouse	BP 27617
AP-HP Hopital Pitie-Salpetriere	Paris	Paris
Institut Cardiovasculaire Paris Sud Hôpital Privé Jacques Cartier	Massy	France
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz	Mainz	Langenbeckstr. 1
Krankenhaus der Barmherzigen Bruder Trier	Trier	Nordallee 1

+ 9 more sites — see the full list on the official registry below.

More Shockwave Medical, Inc. trials in the USA

FORWARD CAD IDE Study Recruiting

Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II Recruiting

Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study) Starting soon

Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE [Investigational Device Exemption] Study) Recruiting

Other trials for the same condition

Virtue® SAB in the Treatment of Coronary ISR Trial Recruiting

A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis Recruiting

Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting Enrolling by invitation

Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) Recruiting

RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05755711 on ClinicalTrials.gov ↗ ← All trials in the USA