Trials / Completed
CompletedNCT02119832
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endovasccular AVF (EndoAVF) | The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2014-04-22
- Last updated
- 2025-11-26
Locations
1 site across 1 country: Paraguay
Source: ClinicalTrials.gov record NCT02119832. Inclusion in this directory is not an endorsement.