Trials / Completed
CompletedNCT01642498
A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension
ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- ROX Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ROX COUPLER | The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein). |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2018-06-30
- Completion
- 2018-06-30
- First posted
- 2012-07-17
- Last updated
- 2019-05-10
Locations
18 sites across 7 countries: Belgium, Germany, Greece, Ireland, Netherlands, Poland, United Kingdom
Source: ClinicalTrials.gov record NCT01642498. Inclusion in this directory is not an endorsement.