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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01642498
First Posted: July 17, 2012
Last Update Posted: September 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ROX Medical, Inc.
  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
Intervention Model: Crossover Assignment
Masking: None (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

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

Primary Outcome Measures:
  • Change in mean office SBP [ Time Frame: Baseline, 6 months ]
    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 ]
    Change in mean office DBP at six months as compared to Baseline


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT01642498


Locations
Belgium
ZNA - Cardio Middleheim
Antwerpen, Belgium, 1090
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Germany
Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, 12203
Universitätsklinikum Erlangen
Erlangen, Germany, D-91054
Hypertoniezentrum Marburg
Marburg, Germany, 35033
Greece
G. Gennimatas General Hospital of Athens
Athens, Greece, 115 27
Hippokration General Hospital of Athens
Athens, Greece, 115 27
Ireland
Connolly Hospital
Blanchardstown, Dublin, Ireland, 15
Beaumont Hospital
Dublin, Ireland, 9
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435CM
Poland
Jagiellonian University Collegium Medicum
Krakow, Poland, 31 501
Institute of Cardiology - Warsaw
Warsaw, Poland, 04 628
United Kingdom
Eastbourne District General Hospital
East Sussex, England, United Kingdom, BN21 2UD
Queen Mary University of London
London, England, United Kingdom, EC1M 6BQ
Royal Bromptom
London, England, United Kingdom, SW3 6NP
St. Helier Hospital
Carshalton, Surrey England, United Kingdom, SM5 1AA
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF 14 4XW
University Hospitals of Leicester - Glenfield Hospital
Leicester, United Kingdom, LE3 9QP
Sponsors and Collaborators
ROX Medical, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ROX Medical, Inc.
ClinicalTrials.gov Identifier: NCT01642498     History of Changes
Other Study ID Numbers: RH-02
First Submitted: July 9, 2012
First Posted: July 17, 2012
Last Update Posted: September 16, 2016
Last Verified: September 2016

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases