Clinical trial NCT05755711: Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Official title: Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: Intravascular Lithotripsy
Percutaneous Coronary Intervention
Lead sponsor: Shockwave Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 399
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care.

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.

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 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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 30 days
measure: Primary Effectiveness Endpoint
timeFrame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates, P.C
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Tulane University Center for Clinical Research
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Manchester,
country: United States
facility: New England Heart and Vascular Institute
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital CRA: Timothy
state: Ohio
city: York
country: United States
facility: WellSpan York Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: MUSC Health University Medical Center
state: South Carolina
city: Nashville
country: United States
facility: Centennial Heart
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: McAllen
country: United States
facility: DHR Health Heart Institute
state: Texas
city: Plano,
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Bellevue
country: United States
facility: Overlake Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Toulouse
country: France
facility: Clinique Pasteur
state: Bp 27617
city: Paris,
country: France
facility: AP-HP Hopital Pitie-Salpetriere
state: Paris
city: Antibes
country: France
facility: Centre Hospitalier d'Antibes
city: Massy
country: France
facility: Institut Cardiovasculaire Paris Sud Hôpital Privé Jacques Cartier
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
state: Langenbeckstr. 1
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Bruder Trier
state: Nordallee 1
city: Leipzig
country: Germany
facility: Heart and Lung Center Leipzig
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico De Santiago
state: A Coruña
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: St. George's Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
References: