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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014