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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.

September 6, 2016
September 9, 2016
November 21, 2018
March 22, 2017
May 2020   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02895386 on ClinicalTrials.gov Archive Site
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
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
Not Provided
Not Provided
 
A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Hypertension
  • High Blood Pressure
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Same as current
June 2020
May 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
22 Years to 85 Years   (Adult, Older Adult)
No
United States
 
 
NCT02895386
US HTN-01
Yes
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
Plan to Share IPD: Undecided
ROX Medical, Inc.
ROX Medical, Inc.
Not Provided
Not Provided
ROX Medical, Inc.
November 2018

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