Blood Pressure, High, Blood Pressure, Resistant, Blood Pressure, Uncontrolled, Hypertension
Conditions
Keywords
Hypertension, High blood pressure, Resistant blood pressure, Uncontrolled blood pressure
Brief summary
The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.
Interventions
DEVICEROX COUPLER
The COUPLER will be used to create an anastomosis 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 resistant or uncontrolled 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 registry, comply with follow-up requirements, or impact the scientific integrity of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ambulatory daytime mean systolic blood pressure | Baseline, 6 months | Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ambulatory daytime mean diastolic blood pressure | Baseline, 6 months | Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline. |
Countries
Belgium, Netherlands, United Kingdom
Outcome results
None listed