Trials / Completed
CompletedNCT02063672
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial Comparing the Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 82 (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 for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lutonix DCB | |
| DEVICE | Standard Uncoated Balloon Angioplasty Catheter | PTA Catheter |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2017-02-13
- Completion
- 2019-03-01
- First posted
- 2014-02-14
- Last updated
- 2019-04-11
- Results posted
- 2018-05-23
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02063672. Inclusion in this directory is not an endorsement.