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Active Clinical Trials

ROX Medical, Inc. - ROX US HTN-01, A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects with Hypertension

Active NCT:
02895386
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
ROX Medical, Inc.
Contact: 

For more information, please contact Sheila Bernardini at 412-359-3281 or Sheila.Bernardini@ahn.org

A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension

Purpose: 

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.

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.
Eligibility Criteria: 
Ages Eligible for Study:   22 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No