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NCT01642498 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01642498
Other study ID # RH-02
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 1, 2012
Est. completion date June 30, 2018

Study information
Verified date May 2019
Source ROX Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium ZNA - Cardio Middleheim Antwerpen
Belgium Universitair Ziekenhuis Brussel Brussels
Germany Universitätsmedizin Berlin - Campus Benjamin Franklin Berlin
Germany Universitätsklinikum Erlangen Erlangen
Germany Hypertoniezentrum Marburg Marburg
Greece G. Gennimatas General Hospital of Athens Athens
Greece Hippokration General Hospital of Athens Athens
Ireland Connolly Hospital Blanchardstown Dublin
Ireland Beaumont Hospital Dublin
Netherlands St. Antonius Ziekenhuis Nieuwegein
Poland Jagiellonian University Collegium Medicum Krakow
Poland Institute of Cardiology - Warsaw Warsaw
United Kingdom University Hospital of Wales Cardiff Wales
United Kingdom St. Helier Hospital Carshalton Surrey England
United Kingdom Eastbourne District General Hospital Eastbourne England
United Kingdom University Hospitals of Leicester - Glenfield Hospital Leicester
United Kingdom Queen Mary University of London London England
United Kingdom Royal Bromptom London England

Sponsors (1)
Lead Sponsor Collaborator
ROX Medical, Inc.

Countries where clinical trial is conducted

Belgium,  Germany,  Greece,  Ireland,  Netherlands,  Poland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in mean office SBP Change in mean office SBP at six months as compared to Baseline Baseline, 6 months
Secondary Change in mean office DBP Change in mean office DBP at six months as compared to Baseline Baseline, 6 months
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