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

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Device: ROX Anastomotic Coupler System (ACS)

• Registration Number: NCT01682057
• Lead Sponsor: ROX Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-10
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-27
• Last Update Posted: 2015-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	ROX Anastomotic Coupler System (ACS)	ROX Anastomic Coupler System (ACS) + 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	Change in mean office DBP six months as compared to Baseline	Change in mean office DBP at six months as compared to Baseline

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium