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 Anastomotic Coupler System (ACS) in patients with severe hypertension.
Interventions
The ROX Anastomic Coupler (ACS) 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
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of severe 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 | Change in mean office DBP six months as compared to Baseline | Change in mean office DBP at six months as compared to Baseline |
Countries
Belgium
Outcome results
None listed