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Clinical Trials in Spain / NCT05755711
Active, not recruiting Observational

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

NCT05755711 · tracked via the Priya Life Science Spain 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
No
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)

FacilityCityRegionStatus
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 Spain

REDUCER-I: An Observational Study of the Neovasc Reducer™ System Active, not recruiting

Other trials for the same condition

Sequent Extended Study Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease Recruiting
Influence of Vessel Wall Calcification on Early Stent Strut Healing Recruiting
COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events Active, not recruiting
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women 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 Spain