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| Overall Recruitment Status: Active, currently enrolling |
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| Official Title |
| Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease |
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
NCT No. |
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NCT05755711 |
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| Study Type |
Phase |
| OBSERVATIONAL |
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| Purpose |
| 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. |
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| Detailed Description |
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- 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)
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- 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
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