A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
Status: Terminated
Location: See all (13) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 85
Healthy Volunteers: f
View:
• Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.
Locations
United States
Alabama
Cardiology P.C. Research
Birmingham
UAB Division of Cardiovascular Disease
Birmingham
Florida
The Cardiac and Vascular Institute Research Foundation
Gainesville
Georgia
Piedmont Heart Institute
Atlanta
Illinois
Prairie Education and Research Cooperative
Springfield
Mississippi
Cardiology Associates Research
Tupelo
North Carolina
Duke University Hospital
Durham
New York
Northwell Health - North Shore University Hospital
Manhasset
Northwell Health - Lenox Hill Hospital
New York
Ohio
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati
The MetroHealth System
Cleveland
OhioHealth Research Institute
Columbus
West Virginia
CAMC Clinical Trials Center
Charleston
Time Frame
Start Date: 2017-03-22
Completion Date: 2019-05-01
Participants
Target number of participants: 30
Treatments
Active_comparator: Treatment Group A
ROX Coupler implantation and continuing antihypertensive medications.
Sham_comparator: Control Group B
Sham procedure and continuing current antihypertensive medications.
Authors
Marat Fudim, James Campbell, Peter Fail, Sachin Goel, Benjamin Blossom, Dean J. Kereiakes, Ilie Barb, Krishna Rocha-Singh, John Szawaluk, Satish Muluk, Andrew Miller, Andrew Galmer, Matheen Khuddus, Indu Poornima, Gary Roubin, Suzanne Oparil, Mitchell Silver, Farrell O Mendelsohn, Judith Veis, Dvorah Holtzman, Vinod Nair, Thomas Todoran, Mohammad Tabesh, Mark Dunlap, Mitchell D Weinberg, Alain Bouchard, Mark Bates, David Kandzari, Suzanne Zentko, Nelson Bernardo, Roger Williams, Barry Bertolet, Michael Zile, Talal T Attar, Sanjay Gandhi, Crystal Tyson, Sreekanth Vemulapalli, Gautham Viswanathan, Arthur Lee
Related Therapeutic Areas
Sponsors
Leads: ROX Medical, Inc.