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

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

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ZNA - Cardio Middleheim, Antwerp, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ROX COUPLER

Device

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

Primary outcomes

Change in mean office SBP

Time frame: Baseline, 6 months

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

Secondary outcomes

Change in mean office DBP

Time frame: Baseline, 6 months

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

Sponsors and collaborators

Lead sponsor

ROX Medical, Inc.

Industry

Registry information

Official study title

ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2018
First posted: Jul 17, 2012
Registry last updated: May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed