Trials / Completed
CompletedNCT05858905
FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter
Forward-Shifted Intravascular Lithotripsy (IVL) Technology in a Prospective, Multi-center, Single-arm Investigational Device Exemption (IDE) Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Shockwave Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intravascular Lithotripsy | The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Not for use in the coronary or cerebral vasculature. |
Timeline
- Start date
- 2023-06-27
- Primary completion
- 2024-04-05
- Completion
- 2025-04-21
- First posted
- 2023-05-15
- Last updated
- 2025-06-26
- Results posted
- 2025-06-26
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05858905. Inclusion in this directory is not an endorsement.