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

This study is currently recruiting participants.
Verified June 2013 by ROX Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01642498
First received: July 9, 2012
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with 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 2015
Estimated Primary Completion Date: June 2015 (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 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
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: June 12, 2013
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 April 17, 2014