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

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ClinicalTrials.gov Identifier: NCT02895386
Recruitment Status : Recruiting
First Posted : September 9, 2016
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
ROX Medical, Inc.

Tracking Information
First Submitted Date  ICMJE September 6, 2016
First Posted Date  ICMJE September 9, 2016
Last Update Posted Date November 21, 2018
Actual Study Start Date  ICMJE March 22, 2017
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02895386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2016)
Change in mean 24-hour Ambulatory Blood Pressure Monitor diastolic blood pressure [ Time Frame: Baseline, 6 months ]
Change in mean 24-hour Ambulatory Blood Pressure Monitor diastolic blood pressure at six months as compared to Baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
Official Title  ICMJE A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • High Blood Pressure
Intervention  ICMJE
  • Device: ROX Coupler
    ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
  • Other: Sham procedure
    Sham procedure + continuing current antihypertensive medications.
Study Arms  ICMJE
  • Active Comparator: Treatment Group A
    ROX Coupler implantation and continuing antihypertensive medications.
    Intervention: Device: ROX Coupler
  • Sham Comparator: Control Group B
    Sham procedure and continuing current antihypertensive medications.
    Intervention: Other: Sham procedure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2016)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02895386
Other Study ID Numbers  ICMJE US HTN-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party ROX Medical, Inc.
Study Sponsor  ICMJE ROX Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ROX Medical, Inc.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP