Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multicenter Study to Evaluate the ROX Arteriovenous Coupler in Patients With Treatment-Resistant Hypertension

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.
 
ClinicalTrials.gov Identifier: NCT01642498
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : May 10, 2019
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 COUPLER in patients with treatment-resistant hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Device: ROX COUPLER Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ROX CONTROL HTN Study: A Prospective, Randomized, Open-Label, Multicenter Study to Evaluate the ROX Coupler in Patients With Resistant Hypertension
Actual Study Start Date : September 1, 2012
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
ROX Coupler + continuing standard antihypertensive medications
Device: ROX COUPLER
The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).

No Intervention: Group B
Continuing standard antihypertensive medications



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: Baseline, 6 months ]
    Change in mean office DBP at six months as compared to Baseline



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of treatment-resistant 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): NCT01642498


Locations
Show Show 18 study locations
Sponsors and Collaborators
ROX Medical, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: ROX Medical, Inc.
ClinicalTrials.gov Identifier: NCT01642498    
Other Study ID Numbers: RH-02
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Keywords provided by ROX Medical, Inc.:
High Blood Pressure
Hypertension
Resistant Hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases