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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 : November 21, 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

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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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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United States, Alabama
Cardiology P.C. Research Recruiting
Birmingham, Alabama, United States, 35211
Contact: Susan DeRamus, RN, CCRN    205-949-5244   
Principal Investigator: Farrell O Mendelsohn, MD         
Sub-Investigator: Alain Bouchard, MD         
UAB Division of Cardiovascular Disease Recruiting
Birmingham, Alabama, United States, 35294
Contact: Michele N Blue, BSN,RN    205-975-4336   
Contact: Rebecca St. John    205-934-7279   
Principal Investigator: Adam Beck, MD         
Sub-Investigator: Suzanne Oparil, 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   
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         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Festus Oyedokun, MBBS MPH CCRC    (404)-605-2327   
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   
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   
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   
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   
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   
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   
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   
Principal Investigator: Mark Dunlap, MD         
Sub-Investigator: Sanjay Gandhi, MD         
OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Katie Waddell, CCRC    614-566-1250   
Principal Investigator: Mitchell Silver, MD         
United States, West Virginia
CAMC Clinical Trials Center Recruiting
Charleston, West Virginia, United States, 25304
Contact: Mariah Preast, MS    304-388-9944   
Principal Investigator: Mark Bates, MD         
Sub-Investigator: James Campbell, MD         
Sponsors and Collaborators
ROX Medical, Inc.

Additional Information:
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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: November 21, 2018
Last Verified: November 2018
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.:
High Blood Pressure
Systolic Blood Pressure
Uncontrolled Hypertension
Essential Hypertension
Resistant Hypertension
Vascular Disease

Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents