Trials / Completed
CompletedNCT05058456
Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System
Prospective, Multi-center, Single-arm Feasibility Study of the Shockwave Medical Mini S Peripheral Intravascular Lithotripsy (IVL) System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Shockwave Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Shockwave Medical Mini S Peripheral IVL Catheter | The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature. |
Timeline
- Start date
- 2022-03-16
- Primary completion
- 2023-12-19
- Completion
- 2024-12-05
- First posted
- 2021-09-27
- Last updated
- 2025-06-08
- Results posted
- 2025-06-08
Locations
4 sites across 2 countries: Australia, New Zealand
Source: ClinicalTrials.gov record NCT05058456. Inclusion in this directory is not an endorsement.