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CompletedNCT01642498Updated May 10, 2019

A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension

A Phase 3 interventional study of ROX COUPLER in Hypertension, sponsored by ROX Medical, Inc.. Completed at 18 sites in 7 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-10.

Sponsored by ROX Medical, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.

02

Conditions studied

  • Hypertension

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Keywords

  • High Blood Pressure
  • Hypertension
  • Resistant Hypertension
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

ROX Medical, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of treatment-resistant hypertension must be made on the basis of current findings, medical history, and physical examination

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Group A

    ROX Coupler + continuing standard antihypertensive medications

    Device: ROX COUPLER

  • No intervention
    Group B

    Continuing standard antihypertensive medications

Interventions

  • DeviceROX COUPLER

    The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).

06

What researchers measure

Primary outcomes

  1. Change in mean office SBP

    Change in mean office SBP at six months as compared to Baseline

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Change in mean office DBP

    Change in mean office DBP at six months as compared to Baseline

    Time frame: Baseline, 6 months

07

Study locations

18 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 29061728 ↗
  • 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. PubMed 28003251 ↗
  • 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. PubMed 25620016 ↗
  • 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. PubMed 25345578 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2012 to primary completion in Jun 2018, 69 months.

Of 178 industry-sponsored phase 3 interventional studies under Hypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's 69 months is above that.

Counting every sponsor, half of 229 studies reached it within 23 months; a quarter within 13 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2012
First posted
Jul 17, 2012
StartActual
Sep 1, 2012
Primary completionActual
Jun 30, 2018
CompletionActual
Jun 30, 2018
Last update
May 10, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01642498
Lead sponsor
ROX Medical, Inc.
Responsible party
Sponsor
First posted
Jul 17, 2012
Start date
Sep 1, 2012
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
May 10, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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