Trials / Completed
CompletedNCT02561299
Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK) lesions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Peripheral Orbital Atherectomy System | Orbital Atherectomy |
| DEVICE | 014 Drug Coated Balloon | Drug Coated Balloon |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2019-07-02
- Completion
- 2019-07-02
- First posted
- 2015-09-28
- Last updated
- 2023-07-18
- Results posted
- 2021-09-16
Locations
7 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT02561299. Inclusion in this directory is not an endorsement.