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

Coronary Artery Disease Clinical Trial

— EMPOWER CAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05755711
• Other study ID #: CP 67712
• Status: Recruiting
• Start date: May 3, 2023
• Est. completion date: April 2028

Study information

• Verified date: April 2024
• Source: Shockwave Medical, Inc.
• Contact: Randee Randoll
• Phone: +1.408.577.7856
• Email: rrandoll[@]shockwavemedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2028
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Clinico De Santiago	Santiago De Compostela	A Coruña
United States	Northside Hospital	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	NYU Langone Health	Brooklyn	New York
United States	MUSC Health University Medical Center	Charleston	South Carolina
United States	The Lindner Center for Research and Education at The Christ Hospital CRA: Timothy	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Northwestern University	Evanston	Illinois
United States	Inova Fairfax Medical Campus	Falls Church	Virginia
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	South Denver Cardiology Associates, P.C	Littleton	Colorado
United States	Loma Linda University Health	Loma Linda	California
United States	Good Samaritan Hospital	Los Angeles	California
United States	New England Heart and Vascular Institute	Manchester	New Hampshire
United States	DHR Health Heart Institute	McAllen	Texas
United States	Centennial Heart	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Tulane University Center for Clinical Research	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	NYU Langone Health	New York	New York
United States	UNMC Heart & Vascular Research Office	Omaha	Nebraska
United States	Baylor Scott & White Research Institute	Plano	Texas
United States	Rhode Island Hospital	Providence	Rhode Island
United States	St. Francis Hospital	Roslyn	New York
United States	Kaiser Permanente - San Francisco Medical Center	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	WellSpan York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Shockwave Medical, Inc.

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint	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).	30 days
Primary	Primary Effectiveness Endpoint	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 6 hours post procedure