High Blood Pressure, Hypertension
Conditions
Keywords
Hypertension, High Blood Pressure, Systolic Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Vascular Disease
Brief 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.
Interventions
DEVICEROX Coupler
ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
OTHERSham procedure
Sham procedure + continuing current antihypertensive medications.
Sponsors
ROX Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.
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 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure | Baseline, 6 months | Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean office systolic blood pressure | Baseline, 6 months | Change in mean office systolic blood pressure at six months as compared to Baseline |
Countries
United States
Outcome results
None listed