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

Not Applicable

Terminated

• Conditions: High Blood Pressure; Hypertension
• Interventions: Device: ROX Coupler; Other: Sham procedure

• Registration Number: NCT02895386
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-09
• Study Start: 2017-03-22
• Status Verified: 2019-05
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group A	ROX Coupler	ROX Coupler implantation and continuing antihypertensive medications.
Control Group B	Sham procedure	Sham procedure and continuing current antihypertensive medications.

Primary Outcome Measures

Name	Time	Method
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure	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

Name	Time	Method
Change in mean office systolic blood pressure	Baseline, 6 months	Change in mean office systolic blood pressure at six months as compared to Baseline

Trial Locations

Locations (13)

Prairie Education and Research Cooperative; 🇺🇸 Springfield, Illinois, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

The Lindner Center for Research and Education at The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

OhioHealth Research Institute; 🇺🇸 Columbus, Ohio, United States

The MetroHealth System; 🇺🇸 Cleveland, Ohio, United States

UAB Division of Cardiovascular Disease; 🇺🇸 Birmingham, Alabama, United States

Cardiology P.C. Research; 🇺🇸 Birmingham, Alabama, United States

Cardiology Associates Research; 🇺🇸 Tupelo, Mississippi, United States

Northwell Health - Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Northwell Health - North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

The Cardiac and Vascular Institute Research Foundation; 🇺🇸 Gainesville, Florida, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

CAMC Clinical Trials Center; 🇺🇸 Charleston, West Virginia, United States