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

July 28, 2026 updated by: Shockwave Medical, Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
399

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Massy, France, 91300
        • Institut Cardiovasculaire Paris Sud Hôpital Privé Jacques Cartier
    • Antibes
      • Antibes, Antibes, France, 06606
        • Centre Hospitalier d'Antibes
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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)
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).
within 30 days of index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
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.
12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
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.
12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
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.
12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
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)
1 year post procedure
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)
2 years post procedure
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)
3 years post procedure
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.
within 30 days of index procedure
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.
1 year post procedure
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.
2 years post procedure
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.
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
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
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
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
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
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)
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
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)
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
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)
3 years post procedure
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.
12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure
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.
within 30 days of index procedure
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.
1 year post procedure
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.
2 years post procedure
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.
3 years post procedure
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.
From baseline to within 30 days of index procedure
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.
From baseline to within 1 year of index procedure
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.
From baseline to within 2 years of index procedure
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.
From baseline to within 3 years of index procedure
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.
From baseline to within 30 days of index procedure
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.
From baseline to within 1 year of index procedure
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.
From baseline to within 2 years of index procedure
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.
From baseline to within 3 years of index procedure
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).
From baseline to within 30 days of index procedure
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).
From baseline to within 1 year of index procedure
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).
From baseline to within 2 years of index procedure
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).
From baseline to within 3 years of index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shockwave Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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