Registry to Evaluate the ROX COUPLER in Patients With Resistant or Uncontrolled Hypertension

This study is currently recruiting participants.

See

Contacts and Locations

Verified September 2016 by ROX Medical, Inc.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01885390

First Posted: June 25, 2013

Last Update Posted: September 16, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Information provided by (Responsible Party):

ROX Medical, Inc.

Purpose

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

Condition	Intervention	Phase
Hypertension Blood Pressure, High Blood Pressure, Resistant Blood Pressure, Uncontrolled	Device: ROX COUPLER	Phase 3


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients With Resistant or Uncontrolled Hypertension

Further study details as provided by ROX Medical, Inc.:

Primary Outcome Measures:

Change in ambulatory daytime mean systolic blood pressure [ Time Frame: Baseline, 6 months ]
Change in mean ambulatory daytime systolic blood pressure at six months as compared to Baseline.

Secondary Outcome Measures:

Change in ambulatory daytime mean diastolic blood pressure [ Time Frame: Baseline, 6 months ]
Change in mean ambulatory daytime diastolic blood pressure at six months as compared to Baseline.


Estimated Enrollment:	100
Study Start Date:	March 2014
Estimated Study Completion Date:	June 2019
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Experimental: Group A ROX Coupler + continuing standard antihypertensive medications	Device: ROX COUPLER The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of resistant or uncontrolled hypertension must be made on the basis of current findings, medical history, and physical examination.

Exclusion Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885390

Locations


Belgium
ZNA Cardio Middelheim	Recruiting
Antwerp, Belgium, 2020
Contact: Benjamin Scott, MD +32 3 280 32 09
Contact: Martine Oreglia, RN +32 3 280 32 09 mi.stusec-cardiologie@xna.be
Netherlands
St. Antonius Ziekenhuis	Recruiting
Nieuwegein, Netherlands, 3435CM
Contact: Benno J. Rensing, MD +31 30 609 3267 b.rensing@antoniusziekenhuis.nl
Contact: Manfred Oostveen, RN +31 30 609 3267 ch.oostveen@antoniusziekenhuis.nl
United Kingdom
East Sussex Healthcare NHS Trust	Recruiting
East Sussex, United Kingdom, BN21 2UD
Contact: Steve Furniss, MD steve.furniss@esht.nhs.uk
Contact: Sarah Bridgland, BS sarah.bridgland@esht.uk
Queen Mary University of London	Recruiting
London, United Kingdom, EC1M 6BQ
Contact: Mel Lobo, MD 020 7882 3416 m.d.lobo@qmul.ac.uk
Contact: Anne Zak, RN 020 7882 5660 a.zak@qmul.ac.uk
Principal Investigator: Mel Lobo, MD

Sponsors and Collaborators

ROX Medical, Inc.

Investigators


Principal Investigator:	Mel Lobo, MD	Queen Mary University of London

More Information


Responsible Party:	ROX Medical, Inc.
ClinicalTrials.gov Identifier:	NCT01885390 History of Changes
Other Study ID Numbers:	RH-03
First Submitted:	June 20, 2013
First Posted:	June 25, 2013
Last Update Posted:	September 16, 2016
Last Verified:	September 2016

Keywords provided by ROX Medical, Inc.:


Hypertension High blood pressure Resistant blood pressure Uncontrolled blood pressure

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases

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