Trials / Active Not Recruiting
Active Not RecruitingNCT05007925
Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System
Prospective, Multi-center, Single-arm Study of the Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System for Treatment of Calcified Peripheral Arterial Disease (PAD) in Below-the-Knee (BTK) Arteries
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Shockwave Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries. Post-market, prospective , multi-center, single-arm study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intravascular Lithotripsy | Localized peripheral intravascular lithotripsy |
Timeline
- Start date
- 2021-11-18
- Primary completion
- 2024-03-25
- Completion
- 2026-04-01
- First posted
- 2021-08-17
- Last updated
- 2025-08-05
- Results posted
- 2025-08-05
Locations
43 sites across 2 countries: United States, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05007925. Inclusion in this directory is not an endorsement.