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

This study is currently recruiting participants.
Verified April 2014 by ROX Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01885390
First received: June 20, 2013
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Hypertension
Blood Pressure, High
Blood Pressure, Resistant
Blood Pressure, Uncontrolled
Device: ROX COUPLER
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension

Resource links provided by NLM:


Further study details as provided by ROX Medical, Inc.:

Primary Outcome Measures:
  • Change in ambulatory daytime mean systolic blood pressure [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline.


Secondary Outcome Measures:
  • Change in ambulatory daytime mean diastolic blood pressure [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline.


Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental: Group A
ROX Coupler + continuing standard antihypertensive medications
Device: ROX COUPLER
The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination.

Exclusion Criteria:

  • Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the registry, comply with follow-up requirements, or impact the scientific integrity of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01885390

Locations
United Kingdom
East Sussex Healthcare NHS Trust Not yet recruiting
East Sussex, United Kingdom, BN21 2UD
Contact: Steve Furniss, MD       steve.furniss@esht.nhs.uk   
Contact: Sarah Bridgland, BS       sarah.bridgland@esht.uk   
Queen Mary University of London Recruiting
London, United Kingdom, EC1M 6BQ
Contact: Mel Lobo, MD    020 7882 3416    m.d.lobo@qmul.ac.uk   
Contact: Anne Zak, RN    020 7882 5660    a.zak@qmul.ac.uk   
Principal Investigator: Mel Lobo, MD         
Sponsors and Collaborators
ROX Medical, Inc.
Investigators
Principal Investigator: Mel Lobo, MD Queen Mary University of London
  More Information

No publications provided

Responsible Party: ROX Medical, Inc.
ClinicalTrials.gov Identifier: NCT01885390     History of Changes
Other Study ID Numbers: RH-03
Study First Received: June 20, 2013
Last Updated: April 17, 2014
Health Authority: England: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ROX Medical, Inc.:
Hypertension
High blood pressure
Resistant blood pressure
Uncontrolled blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014