Trials / Completed
CompletedNCT01870401
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon Versus Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries(Lutonix BTK Trial)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 442 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lutonix DCB | |
| DEVICE | Uncoated PTA Catheter |
Timeline
- Start date
- 2013-06-03
- Primary completion
- 2018-05-17
- Completion
- 2021-06-22
- First posted
- 2013-06-06
- Last updated
- 2022-02-09
- Results posted
- 2020-08-12
Locations
51 sites across 8 countries: United States, Austria, Belgium, Canada, Germany, Italy, Japan, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01870401. Inclusion in this directory is not an endorsement.