Active — Not RecruitingNot Applicable

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

United States399 participantsStarted 2023-05-03

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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

What they're measuring

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

Timeframe: within 30 days of index procedure

Primary Effectiveness Endpoint: Procedural Success

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

Trial details

NCT IDNCT05755711

SponsorShockwave Medical, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-11

Results submitted2025-11-12

View on ClinicalTrials.gov More Coronary Artery Disease trials