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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 : Recruiting
First Posted : September 9, 2016
Last Update Posted : September 10, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

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
United States, Alabama
Cardiology P.C. Research Recruiting
Birmingham, Alabama, United States, 35211
Contact: Kris Armstrong, RN    205-781-1793    karmstrong@cardiologypc.com   
Contact: Susan Deramus, RN, CCRN    205-949-5244    sderamus@cardiologypc.com   
Principal Investigator: Farrell O Mendelsohn, MD         
Sub-Investigator: Alain Bouchard, MD         
Cardiovascular Associates of the Southeast Recruiting
Birmingham, Alabama, United States, 35243
Contact: Tammy Stover, RN, CCRC    205-795-5193    tstover@cvapc.com   
Principal Investigator: Gary Roubin, MD         
Sub-Investigator: Andrew Miller, MD         
United States, District of Columbia
Medstar Heart and Vascular Institute at Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Suman Singh, MD MPH CCRC    202-877-8475    suman.singh@medstar.net   
Principal Investigator: Nelson Bernardo, MD         
Sub-Investigator: Judith Veis, MD         
United States, Florida
The Cardiac and Vascular Institute Research Foundation Recruiting
Gainesville, Florida, United States, 32605
Contact: Alice Boyette, LPN CCRC CCRP    352-244-0208 Option 1    aboyette@tcavi.com   
Principal Investigator: Matheen Khuddus, MD         
Sub-Investigator: Arthur Lee, MD         
Sub-Investigator: Suzanne Zentko, MD         
Sub-Investigator: James O'Meara, MD         
Sub-Investigator: Ilie Barb, MD         
Sub-Investigator: Daniel Van Roy, MD         
Florida Hospital Tampa Recruiting
Tampa, Florida, United States, 33613
Contact: Juliet Bala, BS, CCRC    813-615-7200 ext 56505    Juliet.Bala@ahss.org   
Principal Investigator: Mohammad Tabesh, MD         
Sub-Investigator: Charles Lambert, Jr., MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Festus Oyedokun, MBBS MPH CCRC    (404)-605-2327    Festus.Oyedokun@piedmont.org   
Principal Investigator: David Kandzari, MD         
Principal Investigator: Gautham Viswanathan, MD         
United States, Illinois
Prairie Education and Research Cooperative Recruiting
Springfield, Illinois, United States, 62769
Contact: Meghan Hubrich, RN BSN CCRC    217-492-9100 ext 29126    MHubrich@prairieresearch.com   
Principal Investigator: Sachin Goel, MD         
Sub-Investigator: Krishna Rocha-Singh, MD         
United States, Mississippi
Cardiology Associates Research Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Kristin Eads, RN BSN CCRP    662-620-6875    keads@nmhs.net   
Principal Investigator: Barry Bertolet, MD         
Sub-Investigator: Benjamin Blossom, MD         
Sub-Investigator: Joseph Adams, MD         
Sub-Investigator: Amit Gupta, MD         
Sub-Investigator: Roger Williams, MD         
United States, New York
Northwell Health - North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Theresa Yirerong, RN    516-562-2653    TYirerong@northwell.edu   
Principal Investigator: Mitchell D Weinberg, MD         
Sub-Investigator: Andrew Galmer, MD         
Northwell Health - Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Allison O'Regan, CRC    212-434-3695    aoregan@northwell.edu   
Principal Investigator: Mitchell D Weinberg, MD         
Sub-Investigator: Dvorah Holtzman, MD         
United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: Aarti Kenjale, MBBS MS CRC    919-681-6638    aarti.kenjale@duke.edu   
Principal Investigator: Manesh Patel, MD         
Sub-Investigator: Schuyler Jones, MD         
Sub-Investigator: Crystal Tyson, MD         
Sub-Investigator: Marat Fudim, MD         
Sub-Investigator: Sreekanth Vemulapalli, MD         
United States, Ohio
The Lindner Center for Research and Education at The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Debbie Garza, RN    513-585-1777    deborah.garza@thechristhospital.com   
Principal Investigator: John Szawaluk, MD         
Sub-Investigator: Dean J. Kereiakes, MD         
The MetroHealth System Recruiting
Cleveland, Ohio, United States, 44109
Contact: Pete Leo, RN    216-778-2714    pleo@metrohealth.org   
Principal Investigator: Mark Dunlap, MD         
Sub-Investigator: Sanjay Gandhi, MD         
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Jennifer Smith, RN BSN CCRC    614-685-4624    Jennifer.Smith6@osumc.edu   
Principal Investigator: Talal T Attar, MD         
OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Katie Waddell, CCRC    614-566-1250    Katie.Waddell@ohiohealth.com   
Principal Investigator: Mitchell Silver, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Vijay Paladugu    843-876-5009    paladugc@musc.edu   
Principal Investigator: Thomas Todoran, MD         
Sub-Investigator: Michael Zile, MD         
United States, West Virginia
CAMC Clinical Trials Center Recruiting
Charleston, West Virginia, United States, 25304
Contact: Mariah Preast, MS    304-388-9944    mariah.preast@camc.org   
Principal Investigator: Mark Bates, MD         
Sub-Investigator: James Campbell, MD         
Sponsors and Collaborators
ROX Medical, Inc.

Additional Information:
Publications:
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: September 10, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents