Hypertension
Conditions
Keywords
High Blood Pressure, Hypertension, Resistant Hypertension
Brief summary
The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.
Interventions
DEVICEROX COUPLER
The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
Sponsors
ROX Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of treatment-resistant hypertension must be made on the basis of current findings, medical history, and physical examination
Exclusion criteria
* Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean office SBP | Baseline, 6 months | Change in mean office SBP at six months as compared to Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean office DBP | Baseline, 6 months | Change in mean office DBP at six months as compared to Baseline |
Countries
Belgium, Germany, Greece, Ireland, Netherlands, Poland, United Kingdom
Outcome results
None listed