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

ROX Medical

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Device: ROX COUPLER

Study type: Interventional

Funder types: Industry

Identifiers

NCT01642498

RH-02

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A

Experimental group

Description:

ROX Coupler + continuing standard antihypertensive medications

Treatment:

Device: ROX COUPLER

Group B

No Intervention group

Description:

Continuing standard antihypertensive medications