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

• ClinicalTrials.gov Identifier: NCT05755711
• Recruitment Status: Recruiting
• First Posted: March 6, 2023
• Last Update Posted: May 16, 2024
• Sponsor: Shockwave Medical, Inc.
• Information provided by (Responsible Party): Shockwave Medical, Inc.

Tracking Information

• First Submitted Date: February 21, 2023
• First Posted Date: March 6, 2023
• Last Update Posted Date: May 16, 2024
• Actual Study Start Date: May 3, 2023
• Estimated Primary Completion Date: April 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 2, 2023)

• Primary Safety Endpoint [ Time Frame: 30 days ]
  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).
• Primary Effectiveness Endpoint [ Time Frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 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).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Female patients referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting per standard of care.
• Condition: Coronary Artery Disease

Intervention

Device: Shockwave Medical Coronary IVL System

Coronary Intravascular Lithotripsy (IVL)

Study Groups/Cohorts

Female subjects referred for percutaneous coronary intervention

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

Intervention: Device: Shockwave Medical Coronary IVL System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 2, 2023): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2028
• Estimated Primary Completion Date: April 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: The subject is a non-pregnant female ≥18 years of age, (female sex assigned at birth)

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Randee Randoll; +1.408.577.7856; rrandoll@shockwavemedical.com

• Listed Location Countries: France, Germany, Spain, United States

Administrative Information

• NCT Number: NCT05755711
• Other Study ID Numbers: CP 67712
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Shockwave Medical, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Shockwave Medical, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shockwave Medical, Inc.
• Verification Date: May 2024