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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by ROX Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01642498
First received: July 9, 2012
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Hypertension
Device: ROX COUPLER
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension

Resource links provided by NLM:


Further study details as provided by ROX Medical, Inc.:

Primary Outcome Measures:
  • Change in mean office SBP [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in mean office SBP at six months as compared to Baseline


Secondary Outcome Measures:
  • Change in mean office DBP [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in mean office DBP at six months as compared to Baseline


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
ROX Coupler + continuing standard antihypertensive medications
Device: ROX COUPLER
The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
No Intervention: Group B
Continuing standard antihypertensive medications

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of treatment-resistant 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 study, comply with follow-up requirements or impact the scientific integrity of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642498

Locations
Belgium
ZNA - Cardio Middleheim Recruiting
Antwerpen, Belgium, 1090
Contact: Nancy Aerts, RN    32 3 280 32 09    nancy.aerts@zna.be   
Principal Investigator: Benjamin Scott, MD         
Universitair Ziekenhuis Brussel Recruiting
Brussels, Belgium, 1090
Contact: Ingrid Lemoine, Nursing    +32 (2) 474 9060    ingrid.lemoine@uzbrussel.be   
Contact: Danny Schoors, Dr.    +32 247 63 256    danny.schoors@uzbrussel.be   
Principal Investigator: Danny Schoors, Dr.         
Germany
Universitätsmedizin Berlin - Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Markus van der Giet, MD    49 30 84452379      
Principal Investigator: Markus van der Giet, MD         
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, D-91054
Contact: Roland E. Schmieder, MD       roland.schmieder@uk-erlangen.de   
Principal Investigator: Roland E. Schmieder, MD         
Hypertoniezentrum Marburg Recruiting
Marburg, Germany, 35033
Contact: Danica Nau       naudan@med.uni-marburg.de   
Principal Investigator: Joachim Hoyer, MD         
Greece
G. Gennimatas General Hospital of Athens Recruiting
Athens, Greece, 115 27
Contact: Sousana Tsakalidi       stsakalidi@coronis.gr   
Contact: Varvara Kontomina       vkontomina@coronis.gr   
Principal Investigator: Spyridon Deftereos, MD         
Hippokration General Hospital of Athens Recruiting
Athens, Greece, 115 27
Contact: Sousana Tsakalidi       stsakalidi@coronis.gr   
Contact: Varvara Kontomina       vkontomina@coronis.gr   
Ireland
Connolly Hospital Active, not recruiting
Blanchardstown, Dublin, Ireland, 15
Beaumont Hospital Recruiting
Dublin, Ireland, 9
Contact: Kathleen Shortall, Nurse    353 1 809 2862    kathleenshortall@rcsi.ie   
Principal Investigator: Alice Stanton, MD         
Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands, 3435CM
Contact: Benno J. Rensing, MD       b.rensing@antoniusziekenhuis.nl   
Principal Investigator: Benno J. Rensing, MD         
Poland
Jagiellonian University Collegium Medicum Recruiting
Krakow, Poland, 31 501
Contact: Krzysztof Bartus, MD       cool_chris@interia.pl   
Principal Investigator: Jerzy Sadowski, MD         
Sub-Investigator: Krzysztof Bartus, MD         
Sub-Investigator: Kalina Kawecka-Jaszcz, MD         
Institute of Cardiology - Warsaw Recruiting
Warsaw, Poland, 04 628
Contact: Aleksander Prejbisz, MD, PhD    48223434339    prejbisz@yp.pl   
Contact: Elżbieta Florczak, MD    226108724    florczak@wp.pl   
Principal Investigator: Adam Witkowski, MD         
Sub-Investigator: Andrzej Januszewicz, MD         
Sub-Investigator: Tomasz Kazimierz Grodzicki, MD         
Sub-Investigator: Jacek Kadziela, MD         
United Kingdom
Eastbourne District General Hospital Recruiting
East Sussex, England, United Kingdom, BN21 2UD
Contact: Sveeta Badiani, MD       sveetabadiani@doctors.org.uk   
Principal Investigator: Stephen S. Furniss, MD         
Sub-Investigator: Neil Sulke, MD         
Sub-Investigator: Chakravarthi Rajkumar, MD         
Queen Mary University of London Recruiting
London, England, United Kingdom, EC1M 6BQ
Contact: Anne Zak, Nurse       a.sak@gmul.ac.uk   
Principal Investigator: Mel Lobo, MD         
Sub-Investigator: Mark Caulfield, MD         
Sub-Investigator: Ajay K. Jain, MD         
Sub-Investigator: Manish Saxena, MD         
Sub-Investigator: Charles Knight, MD         
Royal Bromptom Recruiting
London, England, United Kingdom, SW3 6NP
Contact: John Foran, MD       j.foran@rbht.nhs.uk   
Principal Investigator: John Foran, MD         
St. Helier Hospital Recruiting
Carshalton, Surrey England, United Kingdom, SM5 1AA
Contact: Raj Mungur       dhanraj.mungur@esth.nhs.uk   
Principal Investigator: John Foran, MD         
University Hospital of Wales Active, not recruiting
Cardiff, Wales, United Kingdom, CF 14 4XW
University Hospitals of Leicester - Glenfield Hospital Recruiting
Leicester, United Kingdom, LE3 9QP
Contact: G. Andre Ng, Prof.    +44 300 303 1573    gan1@le.ac.uk   
Contact: Kris Kenmuir-Hogg, Nurse    +44 116 2502429    kris.kenmuir-hogg@uhl-tr.nhs.uk   
Principal Investigator: G. Andrew Ng, Prof.         
Sponsors and Collaborators
ROX Medical, Inc.
  More Information

No publications provided

Responsible Party: ROX Medical, Inc.
ClinicalTrials.gov Identifier: NCT01642498     History of Changes
Other Study ID Numbers: RH-02
Study First Received: July 9, 2012
Last Updated: April 17, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by ROX Medical, Inc.:
High Blood Pressure
Hypertension
Resistant Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014