Trials / Terminated
TerminatedNCT04626427
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Post-Market Investigation
The WavelinQ™ Arterio-Venous Endovascular Fistula: A Global, Multi-Center, Prospective, Post-Market, Confirmatory, Interventional, Investigation
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a global, multi-center, prospective, post-market, confirmatory, interventional, non-randomized, single-arm clinical investigation evaluating arteriovenous fistula (AVF) creation by means of the WavelinQ™ EndoAVF System in patients who require a vascular access for hemodialysis (HD).
Detailed description
The purpose of this clinical investigation is to provide clinical evidence to further demonstrate reasonable assurance of safety and effectiveness of the WavelinQ™ EndoAVF System when used for endovascular arteriovenous fistula (endoAVF) creations. Treated participants will be followed for 24-months post index procedure.
Conditions
- End Stage Kidney Disease
- Chronic Kidney Diseases
- Kidney Failure
- Kidney Insufficiency
- Kidney Disease, Chronic
- AV Fistula
- Fistulas Arteriovenous
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WavelinQ™ EndoAVF System | AVF endovascular creations using the WavelinQ™ EndoAVF System |
Timeline
- Start date
- 2020-12-23
- Primary completion
- 2022-06-15
- Completion
- 2022-06-15
- First posted
- 2020-11-12
- Last updated
- 2025-01-16
- Results posted
- 2025-01-16
Locations
3 sites across 3 countries: Belgium, Greece, Switzerland
Source: ClinicalTrials.gov record NCT04626427. Inclusion in this directory is not an endorsement.