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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Hypertension, High Blood Pressure

In brief

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.

Key facts

Study ID

NCT02895386

Run by

ROX Medical, Inc.

People needed

30

Starts

2017-03-22

Expected to finish

2019-05-01

Last updated by the study team

2019-05-13

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.

You may not qualify if…

• 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.

Where it is running

• Cardiology P.C. Research — Birmingham, Alabama, United States
• UAB Division of Cardiovascular Disease — Birmingham, Alabama, United States
• The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Cardiology Associates Research — Tupelo, Mississippi, United States
• Northwell Health - North Shore University Hospital — Manhasset, New York, United States
• Northwell Health - Lenox Hill Hospital — New York, New York, United States
• Duke University Hospital — Durham, North Carolina, United States
• The Lindner Center for Research and Education at The Christ Hospital — Cincinnati, Ohio, United States
• The MetroHealth System — Cleveland, Ohio, United States
• OhioHealth Research Institute — Columbus, Ohio, United States
• CAMC Clinical Trials Center — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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