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A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01682057
First received: September 5, 2012
Last updated: June 12, 2013
Last verified: June 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.


Condition Intervention Phase
Hypertension
 Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)
Device: ROX Anastomotic Coupler System (ACS)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in mean office SBP [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in mean office SBP at six months as compared to Baseline


Secondary Outcome Measures:
  • Change in mean office DBP [ Time Frame: Change in mean office DBP six months as compared to Baseline ] [ Designated as safety issue: No ]
    Change in mean office DBP at six months as compared to Baseline


Estimated Enrollment: 10
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
ROX Anastomic Coupler System (ACS) + continuing standard antihypertensive medications
 Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)
The ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
Device: ROX Anastomotic Coupler System (ACS)

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of severe 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 study, 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: NCT01682057

Locations
Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Sponsors and Collaborators
ROX Medical, Inc.
  More Information

No publications provided

Responsible Party: ROX Medical, Inc.
ClinicalTrials.gov Identifier: NCT01682057     History of Changes
Other Study ID Numbers: RH-01
Study First Received: September 5, 2012
Last Updated: June 12, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by ROX Medical, Inc.:
High Blood Pressure
Hypertension
Resistant Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013