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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02895386
Recruitment Status : Recruiting
First Posted : September 9, 2016
Last Update Posted : January 19, 2018
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

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT02895386

United States, Alabama
Cardiology P.C. Research Recruiting
Birmingham, Alabama, United States, 35211
Contact: Kris Armstrong, RN    205-781-1793   
Contact: Susan Deramus, RN, CCRN    205-949-5244   
Principal Investigator: Farrell O Mendelsohn, MD         
Sub-Investigator: Alain Bouchard, 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, RN    202-877-8475   
Principal Investigator: Nelson Bernardo, MD         
Sub-Investigator: Veis Judith, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Shan Liu, RN    404-605-4098   
Principal Investigator: David Kandzari, MD         
Principal Investigator: Gautham Viswanathan, MD         
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70360
Contact: Deanna K. Benoit, LPN, CCRC    985-873-5613   
Principal Investigator: Peter Fail, MD         
Sub-Investigator: Vinod Nair, MD         
United States, New York
Northwell Health - North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Vidya Seeratan    516-562-2653   
Principal Investigator: Mitchell D Weinberg, MD         
Sub-Investigator: Andrew Galmer, 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   
Principal Investigator: Dean J. Kereiakes, MD         
Sub-Investigator: John Szawaluk, MD         
The MetroHealth System Recruiting
Cleveland, Ohio, United States, 44109
Contact: Pete Leo, RN    216-778-2714   
Principal Investigator: Mark Dunlap, MD         
Sub-Investigator: Sanjay Gandhi, MD         
The Ohio State University Wexner Medical Recruiting
Columbus, Ohio, United States, 43210
Contact: Luba Mazanec    614-566-1266   
Principal Investigator: Talal T Attar, MD         
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Sheila Bernadini, RN    412-359-3281   
Principal Investigator: Satish Muluk, MD         
Sub-Investigator: Indu Poornima, MD         
United States, West Virginia
CAMC Clinical Trials Center Recruiting
Charleston, West Virginia, United States, 25304
Contact: Mariah Preast, RN    304-388-9944   
Principal Investigator: Mark Bates, MD         
Sub-Investigator: James Campbell, MD         
Sponsors and Collaborators
ROX Medical, Inc.

Additional Information:
Responsible Party: ROX Medical, Inc. Identifier: NCT02895386     History of Changes
Other Study ID Numbers: US HTN-01
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 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.:
High Blood Pressure
Systolic Blood Pressure
Uncontrolled Hypertension
Essential Hypertension
Resistant Hypertension
Vascular Disease

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents