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The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | ROX Coupler + continuing standard antihypertensive medications |
|
| Group B | No Intervention | Continuing standard antihypertensive medications |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROX COUPLER | Device | The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean office SBP | Change in mean office SBP at six months as compared to Baseline | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean office DBP | Change in mean office DBP 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 |
|---|---|---|---|---|---|---|
| ZNA - Cardio Middleheim | Antwerp | 1090 | Belgium | |||
| Universitair Ziekenhuis Brussel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29061728 | Derived | 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. | |
| 28003251 |
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| Brussels |
| 1090 |
| Belgium |
| Universitätsmedizin Berlin - Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Universitätsklinikum Erlangen | Erlangen | D-91054 | Germany |
| Hypertoniezentrum Marburg | Marburg | 35033 | Germany |
| G. Gennimatas General Hospital of Athens | Athens | 115 27 | Greece |
| Hippokration General Hospital of Athens | Athens | 115 27 | Greece |
| Connolly Hospital | Blanchardstown | Dublin | 15 | Ireland |
| Beaumont Hospital | Dublin | 9 | Ireland |
| St. Antonius Ziekenhuis | Nieuwegein | 3435CM | Netherlands |
| Jagiellonian University Collegium Medicum | Krakow | 31 501 | Poland |
| Institute of Cardiology - Warsaw | Warsaw | 04 628 | Poland |
| Eastbourne District General Hospital | Eastbourne | England | BN21 2UD | United Kingdom |
| Queen Mary University of London | London | England | EC1M 6BQ | United Kingdom |
| Royal Bromptom | London | England | SW3 6NP | United Kingdom |
| St. Helier Hospital | Carshalton | Surrey England | SM5 1AA | United Kingdom |
| University Hospital of Wales | Cardiff | Wales | CF 14 4XW | United Kingdom |
| University Hospitals of Leicester - Glenfield Hospital | Leicester | LE3 9QP | United Kingdom |
| Derived |
| Ott C, Lobo MD, Sobotka PA, Mahfoud F, Stanton A, Cockcroft J, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Saxena M, Scott B, Ng GA, Achenbach S, Schmieder RE. Effect of Arteriovenous Anastomosis on Blood Pressure Reduction in Patients With Isolated Systolic Hypertension Compared With Combined Hypertension. J Am Heart Assoc. 2016 Dec 21;5(12):e004234. doi: 10.1161/JAHA.116.004234. |
| 25620016 | Derived | 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. |
| 25345578 | Derived | Foran JP, Jain AK, Casserly IP, Kandzari DE, Rocha-Singh KJ, Witkowski A, Katzen BT, Deaton D, Balmforth P, Sobotka PA. The ROX coupler: creation of a fixed iliac arteriovenous anastomosis for the treatment of uncontrolled systemic arterial hypertension, exploiting the physical properties of the arterial vasculature. Catheter Cardiovasc Interv. 2015 Apr;85(5):880-6. doi: 10.1002/ccd.25707. Epub 2014 Nov 1. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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