Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05755711 |
Recruitment Status :
Recruiting
First Posted : March 6, 2023
Last Update Posted : May 1, 2024
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Condition or disease | Intervention/treatment |
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Coronary Artery Disease | Device: Shockwave Medical Coronary IVL System |
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 |
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.
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Device: Shockwave Medical Coronary IVL System
Coronary Intravascular Lithotripsy (IVL) |
- 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).
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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 |
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
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
Contact: Randee Randoll | +1.408.577.7856 | rrandoll@shockwavemedical.com |
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 |
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 |
Intravascular Lithotripsy Percutaneous Coronary Intervention |
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |