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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Device: ROX COUPLER

• Registration Number: NCT01642498
• Lead Sponsor: ROX Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-17
• Study Start: 2012-09-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	ROX COUPLER	ROX Coupler + continuing standard antihypertensive medications

Primary Outcome Measures

Name	Time	Method
Change in mean office SBP	Baseline, 6 months	Change in mean office SBP at six months as compared to Baseline

Secondary Outcome Measures

Name	Time	Method
Change in mean office DBP	Baseline, 6 months	Change in mean office DBP at six months as compared to Baseline

Trial Locations

Locations (18)

ZNA - Cardio Middleheim; 🇧🇪 Antwerpen, Belgium

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium

G. Gennimatas General Hospital of Athens; 🇬🇷 Athens, Greece

Hippokration General Hospital of Athens; 🇬🇷 Athens, Greece

Beaumont Hospital; 🇮🇪 Dublin, Ireland

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Jagiellonian University Collegium Medicum; 🇵🇱 Krakow, Poland

Queen Mary University of London; 🇬🇧 London, England, United Kingdom

Royal Bromptom; 🇬🇧 London, England, United Kingdom

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Universitätsmedizin Berlin - Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Hypertoniezentrum Marburg; 🇩🇪 Marburg, Germany

Institute of Cardiology - Warsaw; 🇵🇱 Warsaw, Poland

Eastbourne District General Hospital; 🇬🇧 Eastbourne, England, United Kingdom

St. Helier Hospital; 🇬🇧 Carshalton, Surrey England, United Kingdom

University Hospital of Wales; 🇬🇧 Cardiff, Wales, United Kingdom

Connolly Hospital; 🇮🇪 Blanchardstown, Dublin, Ireland

University Hospitals of Leicester - Glenfield Hospital; 🇬🇧 Leicester, United Kingdom