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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group A | Active Comparator | ROX Coupler implantation and continuing antihypertensive medications. |
|
| Control Group B | Sham Comparator | Sham procedure and continuing current antihypertensive medications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROX Coupler | Device | ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure | Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean office systolic blood pressure | Change in mean office systolic blood pressure at six months as compared to Baseline | Baseline, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology P.C. Research | Birmingham | Alabama | 35211 | United States | ||
| UAB Division of Cardiovascular Disease |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25620016 | Background | Lobo MD, Sobotka PA, Stanton A, Cockcroft JR, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Scott B, Ng GA, Ott C, Schmieder RE; ROX CONTROL HTN Investigators. Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial. Lancet. 2015 Apr 25;385(9978):1634-41. doi: 10.1016/S0140-6736(14)62053-5. Epub 2015 Jan 23. | |
| 29061728 |
| Label | URL |
|---|---|
| Corporate website | View source |
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| Sham procedure | Other | Sham procedure + continuing current antihypertensive medications. |
|
| Birmingham |
| Alabama |
| 35294 |
| United States |
| The Cardiac and Vascular Institute Research Foundation | Gainesville | Florida | 32605 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Prairie Education and Research Cooperative | Springfield | Illinois | 62769 | United States |
| Cardiology Associates Research | Tupelo | Mississippi | 38801 | United States |
| Northwell Health - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Northwell Health - Lenox Hill Hospital | New York | New York | 10075 | United States |
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| The Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| The MetroHealth System | Cleveland | Ohio | 44109 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| CAMC Clinical Trials Center | Charleston | West Virginia | 25304 | United States |
| Background |
| Lobo MD, Ott C, Sobotka PA, Saxena M, Stanton A, Cockcroft JR, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Scott B, Ng GA, Schmieder RE. Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial. Hypertension. 2017 Dec;70(6):1099-1105. doi: 10.1161/HYPERTENSIONAHA.117.10142. Epub 2017 Oct 23. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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