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

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ClinicalTrials.gov Identifier: NCT01682057
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS) Device: ROX Anastomotic Coupler System (ACS) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Change in mean office SBP [ Time Frame: Baseline, 6 months ]
    Change in mean office SBP at six months as compared to Baseline


Secondary Outcome Measures :
  1. Change in mean office DBP [ Time Frame: Change in mean office DBP six months as compared to Baseline ]
    Change in mean office DBP at six months as compared to Baseline



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682057


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

Responsible Party: ROX Medical, Inc.
ClinicalTrials.gov Identifier: NCT01682057     History of Changes
Other Study ID Numbers: RH-01
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: January 29, 2015
Last Verified: January 2015

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases