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

May 9, 2019 updated by: ROX Medical, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean office SBP
Time Frame: Baseline, 6 months
Change in mean office SBP at six months as compared to Baseline
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean office DBP
Time Frame: Baseline, 6 months
Change in mean office DBP at six months as compared to Baseline
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ROX Medical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2012

Primary Completion (ACTUAL)

June 30, 2018

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

July 9, 2012

First Submitted That Met QC Criteria

July 13, 2012

First Posted (ESTIMATE)

July 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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