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

ROX Medical, Inc.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension High Blood Pressure

Interventions

ROX CouplerDEVICE

ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).

Sham procedureOTHER

Sham procedure + continuing current antihypertensive medications.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (13)

Cardiology P.C. Research

Birmingham, Alabama, United States

UAB Division of Cardiovascular Disease

Birmingham, Alabama, United States

The Cardiac and Vascular Institute Research Foundation

Outcomes

Primary Outcomes

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

Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline

Time frame: Baseline, 6 months

Secondary Outcomes

Change in mean office systolic blood pressure

Change in mean office systolic blood pressure at six months as compared to Baseline

Time frame: Baseline, 6 months

Data from ClinicalTrials.gov

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