NCT02895386

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable hypertension

Geographic Reach
1 country

13 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

September 6, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

March 22, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

September 6, 2016

Last Update Submit

May 9, 2019

Conditions

HypertensionHigh Blood Pressure

Keywords

HypertensionHigh Blood PressureSystolic Blood PressureUncontrolled HypertensionEssential HypertensionResistant HypertensionVascular Disease

Outcome Measures

Primary Outcomes (1)

  • Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure

    Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline

    Baseline, 6 months

Secondary Outcomes (1)

  • Change in mean office systolic blood pressure

    Baseline, 6 months

Study Arms (2)

Treatment Group A

ACTIVE COMPARATOR

ROX Coupler implantation and continuing antihypertensive medications.

Device: ROX Coupler

Control Group B

SHAM COMPARATOR

Sham procedure and continuing current antihypertensive medications.

Other: Sham procedure

Interventions

ROX CouplerDEVICE

ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).

Treatment Group A
Sham procedureOTHER

Sham procedure + continuing current antihypertensive medications.

Control Group B

Eligibility Criteria

Age22 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

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 (13)

Cardiology P.C. Research

Birmingham, Alabama, 35211, United States

Location

UAB Division of Cardiovascular Disease

Birmingham, Alabama, 35294, United States

Location

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, 32605, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62769, United States

Location

Cardiology Associates Research

Tupelo, Mississippi, 38801, United States

Location

Northwell Health - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Northwell Health - Lenox Hill Hospital

New York, New York, 10075, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The MetroHealth System

Cleveland, Ohio, 44109, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

CAMC Clinical Trials Center

Charleston, West Virginia, 25304, United States

Location

Related Publications (2)

  • Lobo MD, Sobotka PA, Stanton A, Cockcroft JR, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Scott B, Ng GA, Ott C, Schmieder RE; ROX CONTROL HTN Investigators. Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial. Lancet. 2015 Apr 25;385(9978):1634-41. doi: 10.1016/S0140-6736(14)62053-5. Epub 2015 Jan 23.

    PMID: 25620016BACKGROUND

  • Lobo MD, Ott C, Sobotka PA, Saxena M, Stanton A, Cockcroft JR, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Scott B, Ng GA, Schmieder RE. Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial. Hypertension. 2017 Dec;70(6):1099-1105. doi: 10.1161/HYPERTENSIONAHA.117.10142. Epub 2017 Oct 23.

    PMID: 29061728BACKGROUND

Related Links

MeSH Terms

Conditions

HypertensionEssential HypertensionVascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 9, 2016

Study Start

March 22, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations

US(13)