Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension
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ClinicalTrials.gov Identifier: NCT01885390 |
Recruitment Status
:
Recruiting
First Posted
: June 25, 2013
Last Update Posted
: March 30, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension Blood Pressure, High Blood Pressure, Resistant Blood Pressure, Uncontrolled | Device: ROX COUPLER | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension |
Study Start Date : | March 2014 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | June 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Experimental: Group A
ROX Coupler + continuing standard antihypertensive medications
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Device: ROX COUPLER
The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
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- Change in ambulatory daytime mean systolic blood pressure [ Time Frame: Baseline, 6 months ]Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline.
- Change in ambulatory daytime mean diastolic blood pressure [ Time Frame: Baseline, 6 months ]Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline.

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination.
Exclusion Criteria:
- Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885390
Belgium | |
ZNA Cardio Middelheim | Recruiting |
Antwerp, Belgium, 2020 | |
Contact: Benjamin Scott, MD +32 3 280 32 09 | |
Contact: Martine Oreglia, RN +32 3 280 32 09 mi.stusec-cardiologie@xna.be | |
Netherlands | |
St. Antonius Ziekenhuis | Recruiting |
Nieuwegein, Netherlands, 3435CM | |
Contact: Benno J. Rensing, MD +31 30 609 3267 b.rensing@antoniusziekenhuis.nl | |
Contact: Manfred Oostveen, RN +31 30 609 3267 ch.oostveen@antoniusziekenhuis.nl | |
United Kingdom | |
East Sussex Healthcare NHS Trust | Recruiting |
Eastbourne, United Kingdom, BN21 2UD | |
Contact: Steve Furniss, MD steve.furniss@esht.nhs.uk | |
Contact: Sarah Bridgland, BS sarah.bridgland@esht.uk | |
Queen Mary University of London | Recruiting |
London, United Kingdom, EC1M 6BQ | |
Contact: Mel Lobo, MD 020 7882 3416 m.d.lobo@qmul.ac.uk | |
Contact: Anne Zak, RN 020 7882 5660 a.zak@qmul.ac.uk | |
Principal Investigator: Mel Lobo, MD |
Principal Investigator: | Mel Lobo, MD | Queen Mary University of London |
Responsible Party: | ROX Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT01885390 History of Changes |
Other Study ID Numbers: |
RH-03 |
First Posted: | June 25, 2013 Key Record Dates |
Last Update Posted: | March 30, 2018 |
Last Verified: | March 2018 |
Keywords provided by ROX Medical, Inc.:
Hypertension High blood pressure Resistant blood pressure Uncontrolled blood pressure |
Additional relevant MeSH terms:
Hypertension Vascular Diseases Cardiovascular Diseases |