Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension

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

PHASE3

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2019-05-05

Brief Summary

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

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Detailed Description

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Conditions

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Hypertension Blood Pressure, High Blood Pressure, Resistant Blood Pressure, Uncontrolled

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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Experimental: Group A

ROX Coupler + continuing standard antihypertensive medications

Group Type EXPERIMENTAL

ROX COUPLER

Intervention Type DEVICE

The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).

Interventions

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ROX COUPLER

The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of resistant or uncontrolled 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 registry, 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