A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension

ROX Medical, Inc.100 enrolled

Overview

The purpose of this study is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Hypertension

Interventions

ROX COUPLERDEVICE

The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of treatment-resistant hypertension must be made on the basis of current findings, medical history, and physical examination 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 (18)

ZNA - Cardio Middleheim

Antwerp, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Outcomes

Primary Outcomes

Change in mean office SBP

Change in mean office SBP at six months as compared to Baseline

Time frame: Baseline, 6 months

Secondary Outcomes

Change in mean office DBP

Change in mean office DBP at six months as compared to Baseline

Time frame: Baseline, 6 months

Data from ClinicalTrials.gov

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