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.
Condition
- Coronary Artery Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned 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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Shockwave Medical, Inc.
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.