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Completed

NCT Number: NCT01682057

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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).

Primary outcomes

  1. Change in mean office SBP

    Time frame: Baseline, 6 months

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

Secondary outcomes

  1. Change in mean office DBP

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

    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

A Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2012
Registry last updated
Jan 29, 2015

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.

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