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NCT Number: NCT05755711

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier d'Antibes, Antibes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is a non-pregnant female ≥18 years of age
  • The subject meets indications for PCI and stent
  • The subject is scheduled to undergo PCI with coronary IVL and stenting per standard of care for non-stented lesion
  • The subject is willing to comply with protocol-specified follow-up evaluations
  • 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

  • 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
  • Subjects presenting with cardiogenic shock at the time of the index procedure
  • 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
  • Subject unable to tolerate anticoagulation/antiplatelet therapy per guidelines
  • Subject is enrolled in any study of an investigational device or drug that may interfere with study results

Treatment and study plan

Shockwave Medical Coronary IVL System

Device

Coronary Intravascular Lithotripsy (IVL)

Primary outcomes

  1. Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF)

    Time frame: 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).

  2. Primary Effectiveness Endpoint: Procedural Success

    Time frame: 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).

Secondary outcomes

  1. Angiographic Success (≤30% Residual Stenosis)

    Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure

    Angiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications.

  2. Procedural Success

    Time frame: 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 stenosis <50% in all target lesions (core laboratory assessed) and without in-hospital TLF.

  3. Angiographic Success (< 50% Residual Stenosis)

    Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure

    Angiographic Success defined as stent delivery with < 50% residual stenosis and without serious angiographic complications.

  4. Serious Angiographic Complications

    Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure

    Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.

  5. Target Lesion Failure (TLF)-1 Year

    Time frame: 1 year post procedure

    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)

  6. Target Lesion Failure (TLF)- 2 Year

    Time frame: 2 years post procedure

    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)

  7. Target Lesion Failure (TLF)- 3 Year

    Time frame: 3 years post procedure

    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)

  8. Major Adverse Cardiac Events (MACE)- 30 Days

    Time frame: within 30 days of index procedure

    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.

  9. Major Adverse Cardiac Events (MACE)- 1 Year

    Time frame: 1 year post procedure

    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.

  10. Major Adverse Cardiac Events (MACE)- 2 Year

    Time frame: 2 years post procedure

    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.

  11. Major Adverse Cardiac Events (MACE)- 3 Year

    Time frame: 3 years post procedure

    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.

  12. 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

    Time frame: 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 (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable) in-hospital

  13. 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

    Time frame: 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 (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)- 30 days

  14. 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

    Time frame: 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 (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)

  15. 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

    Time frame: 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 (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)

  16. 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

    Time frame: 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 (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable)

  17. MI (Myocardial Infarction)- Discharge

    Time frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure

    MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.

  18. MI (Myocardial Infarction)- 30 Day

    Time frame: within 30 days of index procedure

    MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.

  19. MI (Myocardial Infarction)- 1 Year

    Time frame: 1 year post procedure

    MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.

  20. MI (Myocardial Infarction)- 2 Year

    Time frame: 2 years post procedure

    MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.

  21. MI (Myocardial Infarction)- 3 Year

    Time frame: 3 years post procedure

    MI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI.

  22. Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 30 Days

    Time frame: From baseline to within 30 days of index procedure

    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.

  23. Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 1 Year

    Time frame: From baseline to within 1 year of index procedure

    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.

  24. Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 2 Years

    Time frame: From baseline to within 2 years of index procedure

    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.

  25. Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)- Baseline to 3 Years

    Time frame: From baseline to within 3 years of index procedure

    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.

  26. Quality of Life Assessed by EQ-5D-5L- Baseline to 30 Days

    Time frame: From baseline to within 30 days of index procedure

    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.

  27. Quality of Life Assessed by EQ-5D-5L- Baseline to 1 Year

    Time frame: From baseline to within 1 year of index procedure

    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.

  28. Quality of Life Assessed by EQ-5D-5L- Baseline to 2 Year

    Time frame: From baseline to within 2 years of index procedure

    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.

  29. Quality of Life Assessed by EQ-5D-5L- Baseline to 3 Year

    Time frame: From baseline to within 3 years of index procedure

    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.

  30. Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 30 Day

    Time frame: From baseline to within 30 days of index procedure

    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).

  31. Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 1 Year

    Time frame: From baseline to within 1 year of index procedure

    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).

  32. Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 2 Year

    Time frame: From baseline to within 2 years of index procedure

    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).

  33. Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)- Baseline to 3 Year

    Time frame: From baseline to within 3 years of index procedure

    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).

Sponsors and collaborators

Lead sponsor

Shockwave Medical, Inc.

Industry

Registry information

Acronym: EMPOWER CAD

Important dates

Study start
2023
Primary completion
2024
Study completion
2028
First posted
Mar 6, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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