Trials / Completed
CompletedNCT02563535
Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- Ospedale San Donato · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DEB | angioplasty with Litos drug eluting balloon |
| DEVICE | PTA | angioplasty with conventional balloon |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2020-01-01
- Completion
- 2020-01-01
- First posted
- 2015-09-30
- Last updated
- 2020-01-22
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02563535. Inclusion in this directory is not an endorsement.