Trials / Terminated
TerminatedNCT03566927
FLEX®-DCB Dialysis ACCESS Stenosis Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- VentureMed Group Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | FLEX Scoring Catheter with Lutonix DCB | Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB. |
Timeline
- Start date
- 2018-05-29
- Primary completion
- 2019-12-10
- Completion
- 2019-12-10
- First posted
- 2018-06-25
- Last updated
- 2021-02-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03566927. Inclusion in this directory is not an endorsement.