NCT01885390

Brief Summary

The purpose of this registry is to evaluate the safety and performance of the ROX COUPLER in patients with treatment-resistant or uncontrolled hypertension.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_3 hypertension

Geographic Reach
3 countries

4 active sites

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

First Submitted

Initial submission to the registry

June 20, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

5.2 years

First QC Date

June 20, 2013

Last Update Submit

May 9, 2019

Conditions

HypertensionBlood Pressure, HighBlood Pressure, ResistantBlood Pressure, Uncontrolled

Keywords

HypertensionHigh blood pressureResistant blood pressureUncontrolled blood pressure

Outcome Measures

Primary Outcomes (1)

  • Change in ambulatory daytime mean systolic blood pressure

    Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline.

    Baseline, 6 months

Secondary Outcomes (1)

  • Change in ambulatory daytime mean diastolic blood pressure

    Baseline, 6 months

Study Arms (1)

Experimental: Group A

EXPERIMENTAL

ROX Coupler + continuing standard antihypertensive medications

Device: ROX COUPLER

Interventions

ROX COUPLERDEVICE

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

Experimental: Group A

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of resistant or uncontrolled 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 registry, comply with follow-up requirements, or impact the scientific integrity of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

ZNA Cardio Middelheim

Antwerp, 2020, Belgium

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435CM, Netherlands

Location

East Sussex Healthcare NHS Trust

Eastbourne, BN21 2UD, United Kingdom

Location

Queen Mary University of London

London, EC1M 6BQ, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Mel Lobo, MD

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 25, 2013

Study Start

March 1, 2014

Primary Completion

May 5, 2019

Study Completion

May 5, 2019

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations

GB(2)NL(1)BE(1)