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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01642498
First received: July 9, 2012
Last updated: August 27, 2014
Last verified: August 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
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

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: August 27, 2014
Health Authority: Belgium: Ethics Committee

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

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014