Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension

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

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Key information

Conditions

Hypertension Blood Pressure, High Blood Pressure, Resistant Blood Pressure, Uncontrolled Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ZNA Cardio Middelheim, Antwerp, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosis of resistant or uncontrolled 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 registry, 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 anastomosis in the iliac region (between the iliac artery and vein).

Primary outcomes

Change in ambulatory daytime mean systolic blood pressure

Time frame: Baseline, 6 months

Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline.

Secondary outcomes

Change in ambulatory daytime mean diastolic blood pressure

Time frame: Baseline, 6 months

Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline.

Sponsors and collaborators

Lead sponsor

ROX Medical, Inc.

Industry

Registry information

Official study title

ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2019
First posted: Jun 25, 2013
Registry last updated: May 13, 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