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Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension

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ClinicalTrials.gov Identifier: NCT01885390
Recruitment Status : Recruiting
First Posted : June 25, 2013
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.

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

Condition or disease Intervention/treatment Phase
Hypertension Blood Pressure, High Blood Pressure, Resistant Blood Pressure, Uncontrolled Device: ROX COUPLER Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension
Study Start Date : March 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Group A
ROX Coupler + continuing standard antihypertensive medications
 Device: ROX COUPLER
The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).


Outcome Measures
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Primary Outcome Measures :
  1. Change in ambulatory daytime mean systolic blood pressure [ Time Frame: Baseline, 6 months ]
    Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline.


Secondary Outcome Measures :
  1. Change in ambulatory daytime mean diastolic blood pressure [ Time Frame: Baseline, 6 months ]
    Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of resistant or uncontrolled 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 registry, comply with follow-up requirements, or impact the scientific integrity of the study.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01885390


Locations
Belgium
ZNA Cardio Middelheim Recruiting
Antwerp, Belgium, 2020
Contact: Benjamin Scott, MD    +32 3 280 32 09      
Contact: Martine Oreglia, RN    +32 3 280 32 09    mi.stusec-cardiologie@xna.be   
Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands, 3435CM
Contact: Benno J. Rensing, MD    +31 30 609 3267    b.rensing@antoniusziekenhuis.nl   
Contact: Manfred Oostveen, RN    +31 30 609 3267    ch.oostveen@antoniusziekenhuis.nl   
United Kingdom
East Sussex Healthcare NHS Trust Recruiting
Eastbourne, United Kingdom, BN21 2UD
Contact: Steve Furniss, MD       steve.furniss@esht.nhs.uk   
Contact: Sarah Bridgland, BS       sarah.bridgland@esht.uk   
Queen Mary University of London Recruiting
London, United Kingdom, EC1M 6BQ
Contact: Mel Lobo, MD    020 7882 3416    m.d.lobo@qmul.ac.uk   
Contact: Anne Zak, RN    020 7882 5660    a.zak@qmul.ac.uk   
Principal Investigator: Mel Lobo, MD         
Sponsors and Collaborators
ROX Medical, Inc.
Investigators
Principal Investigator: Mel Lobo, MD Queen Mary University of London
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: ROX Medical, Inc.
ClinicalTrials.gov Identifier: NCT01885390     History of Changes
Other Study ID Numbers: RH-03
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by ROX Medical, Inc.:
Hypertension
High blood pressure
Resistant blood pressure
Uncontrolled blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases