CClinicalTrials.gg
Sign In
CompletedNCT01682057Updated Jan 29, 2015

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

A Phase 2 interventional study of ROX ANASTOMOTIC COUPLER SYSTEM (ACS) and ROX Anastomotic Coupler System (ACS) in Hypertension, sponsored by ROX Medical, Inc.. Completed at 1 site in Belgium. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-01-29.

Sponsored by ROX Medical, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.

02

Conditions studied

  • Hypertension

Browse trials for

Keywords

  • High Blood Pressure
  • Hypertension
  • Resistant Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 8 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

ROX Medical, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Group A

    ROX Anastomic Coupler System (ACS) + continuing standard antihypertensive medications

    Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)

Interventions

  • DeviceROX 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).

  • DeviceROX Anastomotic Coupler System (ACS)
06

What researchers measure

Primary outcomes

  1. Change in mean office SBP

    Change in mean office SBP at six months as compared to Baseline

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Change in mean office DBP

    Change in mean office DBP at six months as compared to Baseline

    Time frame: Change in mean office DBP six months as compared to Baseline

07

Study locations

1 site
  • Universitair Ziekenhuis Brussel
    Brussels, 1090, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01682057
Lead sponsor
ROX Medical, Inc.
Responsible party
Sponsor
First posted
Sep 10, 2012
Start date
Oct 2011
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Jan 29, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertension→

Other studies from this sponsor

ROX Medical, Inc.

Start the discussion