A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension (CONTROL HTN-2)

ROX Medical

Status: Terminated

Conditions: Hypertension; High Blood Pressure

Treatments: Other: Sham procedure; Device: ROX Coupler

Study type: Interventional

Funder types: Industry

Identifiers

NCT02895386

US HTN-01

Details and patient eligibility

About

To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.

Enrollment: 30 patients

Sex: All

Ages: 22 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.

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: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Treatment Group A

Active Comparator group

Description:

ROX Coupler implantation and continuing antihypertensive medications.

Treatment:

Device: ROX Coupler

Control Group B

Sham Comparator group

Description:

Sham procedure and continuing current antihypertensive medications.

Treatment:

Other: Sham procedure