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

NCT01642498 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-05-10

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

ROX COUPLER

The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).

Sponsors & Collaborators

  • ROX Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-01
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Belgium
  • Germany
  • Greece
  • Ireland
  • Netherlands
  • Poland
  • United Kingdom

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 NCT01642498 on ClinicalTrials.gov