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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01682057
First Posted: September 10, 2012
Last Update Posted: January 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ROX Medical, Inc.
  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: 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

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

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 8
Study Start Date: October 2011
Study Completion Date: March 2013
Primary Completion Date: March 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  Contacts and Locations
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.
  More Information

Responsible Party: ROX Medical, Inc.
ClinicalTrials.gov Identifier: NCT01682057     History of Changes
Other Study ID Numbers: RH-01
First Submitted: September 5, 2012
First Posted: September 10, 2012
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