Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Shockwave Medical Coronary IVL System

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.

• Study Type: Observational
• Enrollment (Actual): 399

Contacts and Locations

Study Locations

• France
  • Antibes, France, 06606
    • Centre Hospitalier d'Antibes
  • Massy, France, 91300
    • Institut Cardiovasculaire Paris Sud Hôpital Privé Jacques Cartier
  • BP 27617
    • Toulouse, BP 27617, France, 31076 Cedex 3
      • Clinique Pasteur
  • Paris
    • Paris, Paris, France, 75013
      • AP-HP Hopital Pitie-Salpetriere
• Germany
  • Leipzig, Germany
    • Heart and Lung Center Leipzig
  • Langenbeckstr. 1
    • Mainz, Langenbeckstr. 1, Germany, 55131
      • Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
  • Nordallee 1
    • Trier, Nordallee 1, Germany, 54292
      • Krankenhaus der Barmherzigen Brüder Trier
• Spain
  • Barcelona, Spain
    • Hospital del Mar
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain
      • Hospital Clínico de Santiago
• United Kingdom
  • Clydebank, United Kingdom, G81 4HX
    • Golden Jubilee National Hospital
  • Liverpool, United Kingdom, L14 3PE
    • Liverpool Heart and Chest Hospital
  • London, United Kingdom, SW17 0QT
    • St. George's Hospital
  • London, United Kingdom, W12 0HS,
    • Hammersmith Hospital
• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
    • San Francisco, California, United States, 94118
      • Kaiser Permanente - San Francisco Medical Center
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates, P.C
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
    • Atlanta, Georgia, United States, 30308
      • Emory Hospital
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Center for Clinical Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • New England Heart and Vascular Institute
  • New York
    • Brooklyn, New York, United States, 11220
      • NYU Langone Health
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10016
      • NYU Langone Health
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Center for Research and Education at The Christ Hospital CRA: Timothy
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • Wellspan York Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC Health University Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Centennial Heart
  • Texas
    • McAllen, Texas, United States, 78503
      • DHR Health Heart Institute
    • Plano, Texas, United States, 75093
      • Baylor Scott & White Research Institute
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Medical Campus
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Medical Center
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Coronary Intravascular Lithotripsy (IVL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic Success (≤30% Residual Stenosis)	Angiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications.	12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Procedural Success	Procedural Success defined as stent delivery with a residual stenosis <50% in all target lesions (core laboratory assessed) and without in-hospital TLF.	12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Angiographic Success (< 50% Residual Stenosis)	Angiographic Success defined as stent delivery with < 50% residual stenosis and without serious angiographic complications.	12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Serious Angiographic Complications	Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.	12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
Target Lesion Failure (TLF)-1 Year	TFL is defined as a composite of: Cardiac death (see definition within this definition of terms), or; Myocardial Infarction (per SCAI definition for peri-procedural MI; or per Fourth Universal definition for spontaneous MI beyond discharge)-see definition within this definition of terms), or; Ischemia-driven target lesion revascularization-ID-TLR (see definition within this definition of terms)	1 year post procedure
Target Lesion Failure (TLF)- 2 Year	TFL is defined as a composite of: Cardiac death (see definition within this definition of terms), or; Myocardial Infarction (per SCAI definition for peri-procedural MI; or per Fourth Universal definition for spontaneous MI beyond discharge)-see definition within this definition of terms), or; Ischemia-driven target lesion revascularization-ID-TLR (see definition within this definition of terms)	2 years post procedure
Target Lesion Failure (TLF)- 3 Year	TFL is defined as a composite of: Cardiac death (see definition within this definition of terms), or; Myocardial Infarction (per SCAI definition for peri-procedural MI; or per Fourth Universal definition for spontaneous MI beyond discharge)-see definition within this definition of terms), or; Ischemia-driven target lesion revascularization-ID-TLR (see definition within this definition of terms)	3 years post procedure
Major Adverse Cardiac Events (MACE)- 30 Days	Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, myocardial infarction (per SCAI definition for periprocedural MI; per 4th Universal Definition for spontaneous MI beyond discharge), and target vessel revascularization. All MACE were adjudicated by an independent CEC.	within 30 days of index procedure
Major Adverse Cardiac Events (MACE)- 1 Year	Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, myocardial infarction (per SCAI definition for periprocedural MI; per 4th Universal Definition for spontaneous MI beyond discharge), and target vessel revascularization. All MACE were adjudicated by an independent CEC.	1 year post procedure
Major Adverse Cardiac Events (MACE)- 2 Year	Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, myocardial infarction (per SCAI definition for periprocedural MI; per 4th Universal Definition for spontaneous MI beyond discharge), and target vessel revascularization. All MACE were adjudicated by an independent CEC.	2 years post procedure
Major Adverse Cardiac Events (MACE)- 3 Year	Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, myocardial infarction (per SCAI definition for periprocedural MI; per 4th Universal Definition for spontaneous MI beyond discharge), and target vessel revascularization. All MACE were adjudicated by an independent CEC.	3 years post procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- Discharge	All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable) in-hospital	12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure.
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 30 Days	All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)- 30 days	within 30 days of index procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 1 Year	All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)	1 year post procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 2 Year	All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)	2 years post procedure
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis- 3 Year	All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)	3 years post procedure
MI (Myocardial Infarction)- Discharge	MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.	12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
MI (Myocardial Infarction)- 30 Day	MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.	within 30 days of index procedure
MI (Myocardial Infarction)- 1 Year	MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.	1 year post procedure
MI (Myocardial Infarction)- 2 Year	MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.	2 years post procedure
MI (Myocardial Infarction)- 3 Year	MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.	3 years post procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 30 Days	Angina symptoms assessed as a change from baseline by Seattle Angina Questionnaire (SAQ-7). Summary score; 0 to 24 represents poor health status; 25 to 49 represents fair; 50 to 74 represents good; 75 to 100 represents excellent.	From baseline to within 30 days of index procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 1 Year	Angina symptoms assessed as a change from baseline by Seattle Angina Questionnaire (SAQ-7). Summary score; 0 to 24 represents poor health status; 25 to 49 represents fair; 50 to 74 represents good; 75 to 100 represents excellent.	From baseline to within 1 year of index procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 2 Years	Angina symptoms assessed as a change from baseline by Seattle Angina Questionnaire (SAQ-7). Summary score; 0 to 24 represents poor health status; 25 to 49 represents fair; 50 to 74 represents good; 75 to 100 represents excellent.	From baseline to within 2 years of index procedure
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 3 Years	Angina symptoms assessed as a change from baseline by Seattle Angina Questionnaire (SAQ-7). Summary score; 0 to 24 represents poor health status; 25 to 49 represents fair; 50 to 74 represents good; 75 to 100 represents excellent.	From baseline to within 3 years of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 30 Days	Quality of life assessed by EQ-5D-5L as a change from baseline. Summary score; ranges from 0-100; 100 represents the best health you can imagine; 0 represents the worst.	From baseline to within 30 days of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 1 Year	Quality of life assessed by EQ-5D-5L as a change from baseline. Summary score; ranges from 0-100; 100 represents the best health you can imagine; 0 represents the worst.	From baseline to within 1 year of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 2 Year	Quality of life assessed by EQ-5D-5L as a change from baseline. Summary score; ranges from 0-100; 100 represents the best health you can imagine; 0 represents the worst.	From baseline to within 2 years of index procedure
Quality of Life Assessed by EQ-5D-5L- Baseline to 3 Year	Quality of life assessed by EQ-5D-5L as a change from baseline. Summary score; ranges from 0-100; 100 represents the best health you can imagine; 0 represents the worst.	From baseline to within 3 years of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 30 Day	Quality of life assessed by Generalized Anxiety Disorder Questionnaire (GAD-7) as a change from baseline. Total score calculated by summing points (0-3) for each of the seven questions, yielding a total score from 0-21 (at each time period). Minimal Anxiety (0-4); Mild Anxiety (5-9 ); Moderate Anxiety (10-14 ); Severe Anxiety (≥15).	From baseline to within 30 days of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 1 Year	Quality of life assessed by Generalized Anxiety Disorder Questionnaire (GAD-7) as a change from baseline. Total score calculated by summing points (0-3) for each of the seven questions, yielding a total score from 0-21 (at each time period). Minimal Anxiety (0-4); Mild Anxiety (5-9 ); Moderate Anxiety (10-14 ); Severe Anxiety (≥15).	From baseline to within 1 year of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 2 Year	Quality of life assessed by Generalized Anxiety Disorder Questionnaire (GAD-7) as a change from baseline. Total score calculated by summing points (0-3) for each of the seven questions, yielding a total score from 0-21 (at each time period). Minimal Anxiety (0-4); Mild Anxiety (5-9 ); Moderate Anxiety (10-14 ); Severe Anxiety (≥15).	From baseline to within 2 years of index procedure
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 3 Year	Quality of life assessed by Generalized Anxiety Disorder Questionnaire (GAD-7) as a change from baseline. Total score calculated by summing points (0-3) for each of the seven questions, yielding a total score from 0-21 (at each time period). Minimal Anxiety (0-4); Mild Anxiety (5-9 ); Moderate Anxiety (10-14 ); Severe Anxiety (≥15).	From baseline to within 3 years of index procedure

Collaborators and Investigators

• Sponsor: Shockwave Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Actual): December 11, 2024
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Intravascular Lithotripsy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: CP 67712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes