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

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ClinicalTrials.gov Identifier: NCT02895386
Recruitment Status : Terminated (Company/Sponsor has discontinued business)
First Posted : September 9, 2016
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension High Blood Pressure Device: ROX Coupler Other: Sham procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
Actual Study Start Date : March 22, 2017
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   22 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02895386


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

Publications:
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Responsible Party: ROX Medical, Inc.
ClinicalTrials.gov Identifier: NCT02895386     History of Changes
Other Study ID Numbers: US HTN-01
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by ROX Medical, Inc.:
Hypertension
High Blood Pressure
Systolic Blood Pressure
Uncontrolled Hypertension
Essential Hypertension
Resistant Hypertension
Vascular Disease
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents