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A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension

NCT02895386 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-05-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

ROX Coupler

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

OTHER

Sham procedure

Sham procedure + continuing current antihypertensive medications.

Sponsors & Collaborators

  • ROX Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-22
Primary Completion
2019-05-01
Completion
2019-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02895386 on ClinicalTrials.gov