Trials / Active Not Recruiting
Active Not RecruitingNCT05755711
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 399 (actual)
- Sponsor
- Shockwave Medical, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Shockwave Medical Coronary IVL System | Coronary Intravascular Lithotripsy (IVL) |
Timeline
- Start date
- 2023-05-03
- Primary completion
- 2024-12-11
- Completion
- 2028-04-01
- First posted
- 2023-03-06
- Last updated
- 2026-03-27
- Results posted
- 2026-01-22
Locations
49 sites across 5 countries: United States, France, Germany, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05755711. Inclusion in this directory is not an endorsement.