DISCLAIMER: This site is for informational purposes only. While we make every effort to keep it up to date, there is no guarantee that information is complete, accurate, comprehensive, or the same for all KP regions. The information on this site should not be interpreted or used as a substitute for professional medical care. Please consult your care provider for any personal health questions or before participating in clinical trials.

Active, currently enrolling

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

NCT No.: NCT05755711

Study Type: OBSERVATIONAL

Phase:

Region: California - Northern

Acronym: 

Official Title

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

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.

Detailed Description

Sex

Male & Female

Age Limit

Eligibility Criteria

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

Keywords and/or Specific Medical Conditions

  • Cardiology

Sponsors

  • Shockwave Medical

KP Clinical Facility

Clinical Area

  • Cardiology

Principal Investigator

Gopi Manthripragada  

Contact Information

 - CTP Collaborate Team
- CTPCollaborate@kp.org
- All Kaiser Permanente Northern California Medical Centers

Find a study