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.



Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

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

Study Design

Study Type
Observational Model
Time Perspective

Arm Groups

ArmDescriptionAssigned Intervention
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)

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Sadie Swift

More Details

Shockwave Medical, Inc.

Study Contact

Randee Randoll

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 information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.