Trials / Completed
CompletedNCT01558505
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation
Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 142 (actual)
- Sponsor
- Leonardo Bolognese, MD · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PEB | paclitaxel-eluting balloon angioplasty |
| DEVICE | POBA | conventional balloon angioplasty |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2012-09-01
- First posted
- 2012-03-20
- Last updated
- 2013-01-29
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01558505. Inclusion in this directory is not an endorsement.