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

Phase 3

Completed

• Conditions: Hypertension

• 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

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

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

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Hypertoniezentrum Marburg; 🇩🇪 Marburg, Germany

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

Hippokration General Hospital of Athens; 🇬🇷 Athens, Greece

Connolly Hospital; 🇮🇪 Blanchardstown, Dublin, Ireland

Beaumont Hospital; 🇮🇪 Dublin, Ireland

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

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