Trials / Unknown
UnknownNCT02279784
Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- Ospedale San Donato · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to compare in patients with critical limb ischemia the efficacy of angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in terms of restenosis.
Detailed description
Two devices will be evaluated: the Lutonix and the Freeway paclitaxel eluting balloons. A post-hoc analysis will compare the results with the historical data from DEBATE-BTK (NCT01558505).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Freeway PTA | angioplasty with Freeway drug-eluting balloon |
| DEVICE | Lutonix PTA | angioplasty with Lutonix drug-eluting balloon |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-12-01
- Completion
- 2016-10-01
- First posted
- 2014-10-31
- Last updated
- 2014-11-03
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02279784. Inclusion in this directory is not an endorsement.