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

NCT ID: NCT01682057

Last Updated: 2015-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

ROX Anastomic Coupler System (ACS) + continuing standard antihypertensive medications

Group Type EXPERIMENTAL

ROX ANASTOMOTIC COUPLER SYSTEM (ACS)

Intervention Type DEVICE

The ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).

ROX Anastomotic Coupler System (ACS)

Intervention Type DEVICE

Interventions

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ROX ANASTOMOTIC COUPLER SYSTEM (ACS)

The ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).

Intervention Type DEVICE

ROX Anastomotic Coupler System (ACS)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ROX Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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RH-01

Identifier Type: -

Identifier Source: org_study_id

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