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

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

ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

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
      • Antwerp, Belgium, 2020
        • ZNA Cardio Middelheim
  • Netherlands
      • Nieuwegein, Netherlands, 3435CM
        • St. Antonius Ziekenhuis
  • United Kingdom
      • Eastbourne, United Kingdom, BN21 2UD
        • East Sussex Healthcare Nhs Trust
      • London, United Kingdom, EC1M 6BQ
        • Queen Mary University of London

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 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 months

Collaborators and Investigators

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

Sponsor

ROX Medical, Inc.

Investigators

  • Principal Investigator: Mel Lobo, MD, Queen Mary University of London

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)

March 1, 2014

Primary Completion (ACTUAL)

May 5, 2019

Study Completion (ACTUAL)

May 5, 2019

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (ESTIMATE)

June 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 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-03

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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