Trials / Terminated
TerminatedNCT02895386
A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- ROX Medical, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ROX Coupler | ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein). |
| OTHER | Sham procedure | Sham procedure + continuing current antihypertensive medications. |
Timeline
- Start date
- 2017-03-22
- Primary completion
- 2019-05-01
- Completion
- 2019-05-01
- First posted
- 2016-09-09
- Last updated
- 2019-05-13
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02895386. Inclusion in this directory is not an endorsement.