NCT01682057

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2 hypertension

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

1.4 years

First QC Date

September 5, 2012

Last Update Submit

January 27, 2015

Conditions

Hypertension

Keywords

High Blood PressureHypertensionResistant Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in mean office SBP

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

    Baseline, 6 months

Secondary Outcomes (1)

  • Change in mean office DBP

    Change in mean office DBP six months as compared to Baseline

Study Arms (1)

Group A

EXPERIMENTAL

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

Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)

Interventions

ROX Anastomotic Coupler System (ACS)DEVICE

The ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).

Group A

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 10, 2012

Study Start

October 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 29, 2015

Record last verified: 2015-01

Locations

BE(1)