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

ROX Medical

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Device: ROX Anastomotic Coupler System (ACS); Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682057

RH-01

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Group A

Experimental group

Description:

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

Treatment:

Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)