Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension

NCT01885390 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2019-05-13

No results posted yet for this study

Summary

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

Conditions

  • Hypertension
  • Blood Pressure, High
  • Blood Pressure, Resistant
  • Blood Pressure, Uncontrolled

Interventions

DEVICE

ROX COUPLER

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

Sponsors & Collaborators

  • ROX Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Mel Lobo, MD · Queen Mary University of London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-03-01
Primary Completion
2019-05-05
Completion
2019-05-05

Countries

  • Belgium
  • Netherlands
  • United Kingdom

Study Locations

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Entities

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 NCT01885390 on ClinicalTrials.gov