Trials / Completed
CompletedNCT03943160
Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
Detailed description
The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Diamondback 360 Extended Length Orbital Atherectomy System | All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion. |
Timeline
- Start date
- 2019-06-11
- Primary completion
- 2019-12-11
- Completion
- 2019-12-11
- First posted
- 2019-05-09
- Last updated
- 2023-07-18
- Results posted
- 2021-03-03
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03943160. Inclusion in this directory is not an endorsement.