A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension

Phase 2CompletedNCT01682057

ROX Medical, Inc.8 enrolled

Overview

The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

ROX ANASTOMOTIC COUPLER SYSTEM (ACS)DEVICE

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

ROX Anastomotic Coupler System (ACS)DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of severe 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 (1)

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

Data from ClinicalTrials.gov

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