A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:22 - 85
Updated:11/23/2018
Start Date:March 22, 2017
End Date:June 2020

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Trial Summary
Trial Overview
Inclusion Criteria

A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension

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.


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.
We found this trial at
13
sites
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio 45219
Principal Investigator: John Szawaluk, MD
Phone: 513-585-1777
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mi
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Cincinnati, OH
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Piedmont Heart Institute
Atlanta, Georgia 30309
Principal Investigator: David Kandzari, MD
Phone: (404)-605-2327
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mi
from
Atlanta, GA
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Cardiology P.C. Research
801 Princeton Avenue Southwest
Birmingham, Alabama 35211
Principal Investigator: Farrell O Mendelsohn, MD
Phone: 205-949-5244
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mi
from
Birmingham, AL
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UAB Division of Cardiovascular Disease
Birmingham, Alabama 35294
Principal Investigator: Adam Beck, MD
Phone: 205-975-4336
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mi
from
Birmingham, AL
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CAMC Clinical Trials Center
Charleston, West Virginia 25304
Principal Investigator: Mark Bates, MD
Phone: 304-388-9944
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mi
from
Charleston, WV
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MetroHealth System
Cleveland, Ohio 44109
Principal Investigator: Mark Dunlap, MD
Phone: 216-778-2714
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mi
from
Cleveland, OH
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OhioHealth Research Institute
Columbus, Ohio 43214
Principal Investigator: Mitchell Silver, MD
Phone: 614-566-1250
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mi
from
Columbus, OH
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Duke University Hospital
Durham, North Carolina 27705
Principal Investigator: Manesh Patel, MD
Phone: 919-681-6638
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mi
from
Durham, NC
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The Cardiac And Vascular Institute Research Foundation, Llc
Gainesville, Florida 32605
Principal Investigator: Matheen Khuddus, MD
Phone: 352-244-0208 Option 1
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mi
from
Gainesville, FL
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Northwell Health / North Shore University Hospital
Manhasset, New York 11030
Principal Investigator: Mitchell D Weinberg, MD
Phone: 516-562-2653
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mi
from
Manhasset, NY
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Northwell Health - Lenox Hill Hospital
130 East 77th Street
New York, New York 10075
Principal Investigator: Mitchell D Weinberg, MD
Phone: 212-434-3695
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mi
from
New York, NY
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Prairie Education and Research Cooperative
Springfield, Illinois 62701
Principal Investigator: Sachin Goel, MD
Phone: 217-492-9100
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mi
from
Springfield, IL
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Cardiology Associates Research LLC
Tupelo, Mississippi 38801
Principal Investigator: Barry Bertolet, MD
Phone: 662-620-6875
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mi
from
Tupelo, MS
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