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A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension (CONTROL HTN-2)

This study is currently recruiting participants.
Verified September 2017 by ROX Medical, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02895386
First Posted: September 9, 2016
Last Update Posted: September 15, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
ROX Medical, Inc.
  Purpose
To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.

Condition Intervention
Hypertension High Blood Pressure Device: ROX Coupler Other: Sham procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension

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

Primary Outcome Measures:
  • Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure [ Time Frame: Baseline, 6 months ]
    Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline


Secondary Outcome Measures:
  • Change in mean office systolic blood pressure [ Time Frame: Baseline, 6 months ]
    Change in mean office systolic blood pressure at six months as compared to Baseline


Estimated Enrollment: 500
Actual Study Start Date: March 22, 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Group A
ROX Coupler implantation and continuing antihypertensive medications.
Device: ROX Coupler
ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
Sham Comparator: Control Group B
Sham procedure and continuing current antihypertensive medications.
Other: Sham procedure
Sham procedure + continuing current antihypertensive medications.

  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:   22 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.

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): NCT02895386


Locations
United States, Alabama
Cardiology P.C. Research Recruiting
Birmingham, Alabama, United States, 35211
Contact: Kris Armstrong, RN    205-781-1793    karmstrong@cardiologypc.com   
Contact: Susan Deramus, RN, CCRN    205-949-5244    sderamus@cardiologypc.com   
Principal Investigator: Farrell O Mendelsohn, MD         
Sub-Investigator: Alain Bouchard, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Shan Liu, RN    404-605-4098    Shan.Liu@piedmont.org   
Principal Investigator: David Kandzari, MD         
Principal Investigator: Gautham Viswanathan, MD         
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70360
Contact: Deanna K. Benoit, LPN, CCRC    985-873-5613    deanna.benoit@cardio.com   
Principal Investigator: Peter Fail, MD         
Sub-Investigator: Vinod Nair, MD         
United States, New York
Northwell Health - North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Vidya Seeratan    516-562-2653    vseeratan@northwell.edu   
Principal Investigator: Mitchell D Weinberg, MD         
Sub-Investigator: Andrew Galmer, MD         
United States, Ohio
The Lindner Center for Research and Education at The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Debbie Garza, RN    513-585-1777    deborah.garza@thechristhospital.com   
Principal Investigator: Dean J. Kereiakes, MD         
Sub-Investigator: John Szawaluk, MD         
The Ohio State University Wexner Medical Recruiting
Columbus, Ohio, United States, 43210
Contact: Luba Mazanec    614-566-1266    Luba.Mazanec@osumc.edu   
Principal Investigator: Talal T Attar, MD         
United States, West Virginia
CAMC Clinical Trials Center Recruiting
Charleston, West Virginia, United States, 25304
Contact: Joy Hogan, LPN, CCRC    304-388-9957    joy.hogan@camc.org   
Principal Investigator: Mark Bates, MD         
Sub-Investigator: James Campbell, MD         
Sponsors and Collaborators
ROX Medical, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: ROX Medical, Inc.
ClinicalTrials.gov Identifier: NCT02895386     History of Changes
Other Study ID Numbers: US HTN-01
First Submitted: September 6, 2016
First Posted: September 9, 2016
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by ROX Medical, Inc.:
Hypertension
High Blood Pressure
Systolic Blood Pressure
Uncontrolled Hypertension
Essential Hypertension
Resistant Hypertension
Vascular Disease

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents