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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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
Columbus, Ohio 43214
Principal Investigator: Mitchell Silver, MD
Phone: 614-566-1250
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Atlanta, Georgia 30309
Principal Investigator: David Kandzari, MD
Phone: (404)-605-2327
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Atlanta, GA
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801 Princeton Avenue Southwest
Birmingham, Alabama 35211
Principal Investigator: Farrell O Mendelsohn, MD
Phone: 205-949-5244
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Birmingham, AL
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Birmingham, Alabama 35294
Principal Investigator: Adam Beck, MD
Phone: 205-975-4336
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Birmingham, AL
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Charleston, West Virginia 25304
Principal Investigator: Mark Bates, MD
Phone: 304-388-9944
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Charleston, WV
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Cincinnati, Ohio 45219
Principal Investigator: John Szawaluk, MD
Phone: 513-585-1777
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Cincinnati, OH
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Cleveland, Ohio 44109
Principal Investigator: Mark Dunlap, MD
Phone: 216-778-2714
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Cleveland, OH
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Durham, North Carolina 27705
Principal Investigator: Manesh Patel, MD
Phone: 919-681-6638
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Durham, NC
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Gainesville, Florida 32605
Principal Investigator: Matheen Khuddus, MD
Phone: 352-244-0208 Option 1
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Gainesville, FL
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Manhasset, New York 11030
Principal Investigator: Mitchell D Weinberg, MD
Phone: 516-562-2653
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Manhasset, NY
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130 East 77th Street
New York, New York 10075
Principal Investigator: Mitchell D Weinberg, MD
Phone: 212-434-3695
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New York, NY
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Springfield, Illinois 62701
Principal Investigator: Sachin Goel, MD
Phone: 217-492-9100
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Springfield, IL
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Tupelo, Mississippi 38801
Principal Investigator: Barry Bertolet, MD
Phone: 662-620-6875
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Tupelo, MS
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