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

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ClinicalTrials.gov Identifier: NCT01642498
Recruitment Status : Active, not recruiting
First Posted : July 17, 2012
Last Update Posted : September 16, 2016
Information provided by (Responsible Party):
ROX Medical, Inc.

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

Condition or disease Intervention/treatment Phase
Hypertension Device: ROX COUPLER Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : September 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: Group A
ROX Coupler + continuing standard antihypertensive medications
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

Primary Outcome Measures :
  1. 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 :
  1. Change in mean office DBP [ Time Frame: Baseline, 6 months ]
    Change in mean office DBP at six months as compared to Baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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

ZNA - Cardio Middleheim
Antwerpen, Belgium, 1090
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, 12203
Universitätsklinikum Erlangen
Erlangen, Germany, D-91054
Hypertoniezentrum Marburg
Marburg, Germany, 35033
G. Gennimatas General Hospital of Athens
Athens, Greece, 115 27
Hippokration General Hospital of Athens
Athens, Greece, 115 27
Connolly Hospital
Blanchardstown, Dublin, Ireland, 15
Beaumont Hospital
Dublin, Ireland, 9
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435CM
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.

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 Posted: July 17, 2012    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016

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

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases