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The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Group A | Experimental | ROX Coupler + continuing standard antihypertensive medications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROX COUPLER | Device | The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ambulatory daytime mean systolic blood pressure | Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ambulatory daytime mean diastolic blood pressure | Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline. | Baseline, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mel Lobo, MD | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA Cardio Middelheim | Antwerp | 2020 | Belgium | |||
| St. Antonius Ziekenhuis |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Nieuwegein |
| 3435CM |
| Netherlands |
| East Sussex Healthcare NHS Trust | Eastbourne | BN21 2UD | United Kingdom |
| Queen Mary University of London | London | EC1M 6BQ | United Kingdom |