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Trial record 1 of 118 for:    EMPOWER CAD
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Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD)

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ClinicalTrials.gov Identifier: NCT05755711
Recruitment Status : Recruiting
First Posted : March 6, 2023
Last Update Posted : May 1, 2024
Sponsor:
Information provided by (Responsible Party):
Shockwave Medical, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Coronary Artery Disease 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 Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Actual Study Start Date : May 3, 2023
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2028

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Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05755711


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

Locations
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Sponsors and Collaborators
Shockwave Medical, Inc.
More Information
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Responsible Party: Shockwave Medical, Inc.
ClinicalTrials.gov Identifier: NCT05755711    
Other Study ID Numbers: CP 67712
First Posted: March 6, 2023    Key Record Dates
Last Update Posted: May 1, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Shockwave Medical, Inc.:
Intravascular Lithotripsy
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases