A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension
NCT ID: NCT01642498
Last Updated: 2019-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2012-09-01
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group A
ROX Coupler + continuing standard antihypertensive medications
ROX COUPLER
The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
Group B
Continuing standard antihypertensive medications
No interventions assigned to this group
Interventions
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ROX COUPLER
The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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ROX Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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ZNA - Cardio Middleheim
Antwerp, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Hypertoniezentrum Marburg
Marburg, , Germany
G. Gennimatas General Hospital of Athens
Athens, , Greece
Hippokration General Hospital of Athens
Athens, , Greece
Connolly Hospital
Blanchardstown, Dublin, Ireland
Beaumont Hospital
Dublin, , Ireland
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Jagiellonian University Collegium Medicum
Krakow, , Poland
Institute of Cardiology - Warsaw
Warsaw, , Poland
Eastbourne District General Hospital
Eastbourne, England, United Kingdom
Queen Mary University of London
London, England, United Kingdom
Royal Bromptom
London, England, United Kingdom
St. Helier Hospital
Carshalton, Surrey England, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
University Hospitals of Leicester - Glenfield Hospital
Leicester, , United Kingdom
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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RH-02
Identifier Type: -
Identifier Source: org_study_id
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