A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension (CONTROL HTN-2)

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

A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension

To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Division of Cardiovascular Disease
      • Birmingham, Alabama, United States, 35211
        • Cardiology P.C. Research
    • Florida
      • Gainesville, Florida, United States, 32605
        • The Cardiac and Vascular Institute Research Foundation
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
    • Illinois
      • Springfield, Illinois, United States, 62769
        • Prairie Education and Research Cooperative
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Cardiology Associates Research
    • New York
      • Manhasset, New York, United States, 11030
        • NorthWell Health - North Shore University Hospital
      • New York, New York, United States, 10075
        • Northwell Health - Lenox Hill Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Center for Research and Education at The Christ Hospital
      • Cleveland, Ohio, United States, 44109
        • The MetroHealth System
      • Columbus, Ohio, United States, 43214
        • OhioHealth Research Institute
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Clinical Trials Center

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

22 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment Group A
ROX Coupler implantation and continuing antihypertensive medications.
Device: ROX Coupler
ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
Sham Comparator: Control Group B
Sham procedure and continuing current antihypertensive medications.
Other: Sham procedure
Sham procedure + continuing current antihypertensive medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure
Time Frame: Baseline, 6 months
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean office systolic blood pressure
Time Frame: Baseline, 6 months
Change in mean office systolic 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.

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)

March 22, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 9, 2016

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

  • US HTN-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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