A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension
ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension
1 other identifier
interventional
100
7 countries
18
Brief Summary
The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hypertension
Started Sep 2012
Longer than P75 for phase_3 hypertension
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedMay 10, 2019
May 1, 2019
5.8 years
July 9, 2012
May 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean office SBP
Change in mean office SBP at six months as compared to Baseline
Baseline, 6 months
Secondary Outcomes (1)
Change in mean office DBP
Baseline, 6 months
Study Arms (2)
Group A
EXPERIMENTALROX Coupler + continuing standard antihypertensive medications
Group B
NO INTERVENTIONContinuing standard antihypertensive medications
Interventions
The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
Eligibility Criteria
You may qualify if:
- Diagnosis of treatment-resistant hypertension must be made on the basis of current findings, medical history, and physical examination
You may not qualify if:
- Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
ZNA - Cardio Middleheim
Antwerp, 1090, Belgium
Universitair Ziekenhuis Brussel
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
Related Publications (4)
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.
PMID: 29061728DERIVEDOtt 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.
PMID: 28003251DERIVEDLobo 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.
PMID: 25620016DERIVEDForan 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.
PMID: 25345578DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2012
First Posted
July 17, 2012
Study Start
September 1, 2012
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
May 10, 2019
Record last verified: 2019-05