HypertensionPhase 3NCT01642498
A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension
A Phase 3 study testing ROX COUPLER in people with Hypertension, run by ROX Medical, Inc. at 18 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ROX COUPLER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 1 Sep 2012to 30 Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of treatment-resistant hypertension must be made on the basis of current findings, medical history, and physical examination
Who cannot join
- 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.
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
United Kingdom6 sites
University Hospital of Wales
Cardiff, Wales, CF 14 4XW
St. Helier Hospital
Carshalton, Surrey England, SM5 1AA
Eastbourne District General Hospital
Eastbourne, England, BN21 2UD
University Hospitals of Leicester - Glenfield Hospital
Leicester, LE3 9QP
Queen Mary University of London
London, England, EC1M 6BQ
Royal Bromptom
London, England, SW3 6NP
Germany3 sites
Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12203
Universitätsklinikum Erlangen
Erlangen, D-91054
Hypertoniezentrum Marburg
Marburg, 35033
Belgium2 sites
ZNA - Cardio Middleheim
Antwerp, 1090
Universitair Ziekenhuis Brussel
Brussels, 1090
Greece2 sites
G. Gennimatas General Hospital of Athens
Athens, 115 27
Hippokration General Hospital of Athens
Athens, 115 27
Ireland2 sites
Connolly Hospital
Blanchardstown, Dublin, 15
Beaumont Hospital
Dublin, 9
Poland2 sites
Jagiellonian University Collegium Medicum
Krakow, 31 501
Institute of Cardiology - Warsaw
Warsaw, 04 628
About this study
Official title: ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension
The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.
- Conditions
- Hypertension
- Being tested
- ROX COUPLER
- Keywords
- High Blood Pressure, Hypertension, Resistant Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROX COUPLERDevice
The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | ROX Coupler + continuing standard antihypertensive medications Receives: Device: ROX COUPLER |
| Group B | No intervention | Continuing standard antihypertensive medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean office SBP
Change in mean office SBP at six months as compared to Baseline
Measured: Baseline, 6 months
Secondary outcomes (1)
Change in mean office DBP
Change in mean office DBP at six months as compared to Baseline
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study start1 Sep 2012
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ROX Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642498
- Sponsor's protocol ID
- RH-02
- Status last verified
- May 2019
- First submitted
- 9 Jul 2012
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
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 29061728Ott 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 28003251Lobo 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 25620016Foran 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
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01642498
- Acronym / sponsor ID
- RH-02
- Conditions
- Hypertension
- Keywords
- High Blood Pressure, Hypertension, Resistant Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ROX Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: ROX COUPLERROX Coupler + continuing standard antihypertensive medications |
| Group B | No intervention | –Continuing standard antihypertensive medications |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of treatment-resistant hypertension must be made on the basis of current findings, medical history, and physical examination
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROX COUPLERThe COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein). | Device | Group A |
Primary outcome
Change in mean office SBP
Time frame: Baseline, 6 months
Change in mean office SBP at six months as compared to Baseline
1 secondary outcome
Change in mean office DBP
Time frame: Baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Derived from this study: PubMed 29061728Lobo 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.
- Derived from this study: PubMed 28003251Ott 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.
- Derived from this study: PubMed 25620016Lobo 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.
- Derived from this study: PubMed 25345578Foran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ROX COUPLER in people with Hypertension, run by ROX Medical, Inc. at 18 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom, Germany, Belgium, Greece, Ireland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean office SBP (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01642498, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.