About the Clinical Study

About the Clinical Study

The ROX® therapy is intended for people with uncontrolled hypertension. If you take 3 or more blood pressure medications every day, and your systolic blood pressure remains greater than 155 mmHg, or if you’ve been treated in the hospital for your hypertension within the last year, and your blood pressure is greater than 150 mmHg, you may be a candidate for the ROX CONTROL HTN-2 Clinical Trial.

The ROX CONTROL HTN-2 Trial will evaluate the ROX Coupler therapy’s ability to lower uncontrolled blood pressure.

New therapies such as the ROX Coupler may offer patients an option in reducing the risks of high blood pressure. The medical and research community will use data from this trial to continue developing new treatments for hypertension. A chronic condition such as high blood pressure can carry enormous social and economic costs for patients and caregivers. Research such as this may result in new treatment strategies to ease that burden.

You will find study protocol, inclusion/exclusion criteria on the  www.clinicaltrials.gov site.

AM I ELIGIBLE

The ROX Therapy

The ROX Coupler therapy is a minimally invasive procedure performed in an angiography suite or hybrid operating room. The ROX Coupler is a small implantable medical device about the size of a dime. This small device is inserted percutaneously; meaning that small needle-like punctures are made on the skin and thin catheters which are like tubes get inserted in the artery and vein of the upper leg. The Coupler works by creating an anastomosis or passageway, which allows high-pressured blood from the iliac artery to go into the lower pressured iliac vein, which is in your pelvis. The procedure takes about an hour and is performed under local anesthesia.

Your study physician will discuss all of the therapy details.

How the ROX Coupler is Placed

The procedure is performed percutaneously. This means that all procedure steps can be completed using catheters introduced through small needle-like punctures.

Step 1

In the hospital procedure room, X-rays guide device placement.

Step 2

Needle-like punctures allow small catheters (tubes) to be inserted into the upper leg.

Step 3

Using the small catheters, the Coupler is placed and creates a passageway between an artery and a vein.

ROX Coupler Treatment History

There have been three clinical trials in Europe studying the ROX Coupler in patients with high blood pressure. One of these was a randomized study whose results have been reviewed by independent physicians (peer reviewed) and published in The Lancet.

The Risks

All interventional procedures involve risk, some of which can be significant. Risks specific to the ROX Coupler and procedure can also include narrowing of the artery or vein, blood clots, and serious bleeding. Some of these complications may require a second procedure. Your study doctor will provide detailed information and explain all the risks in detail to you.

ROX Coupler Removal

Placement of the Coupler is intended to be permanent. However, unlike other device based approaches, the ROX Coupler can be reversed by undergoing a procedure like the procedure used to place the Coupler. The reversal procedure covers the opening between blood vessels without the need to remove the Coupler.

Eligibility for the ROX CONTROL HTN-2 Clinical Trial

If you take your blood pressure medicine every day, but your systolic blood pressure remains greater than 155 mmHg, you may be a candidate for the ROX CONTROL HTN-2 Clinical Trial. Or if you’ve been treated in the hospital for your hypertension within the last year, and your blood pressure is greater than 150 mmHg, you may be a candidate. You should ask your physician about participating in the study.

Blinded and Randomized Clinical Study

A randomized study means that you will be assigned to one of two groups of patients: a treatment group (those patients who receive the ROX Coupler) or a control group (those patients who do not receive a ROX Coupler). Assignment to the groups is random, which means you will have an equal chance of being assigned to either group. A blinded study means that you and your study doctor will not know which group you have been assigned to. This ensures that your doctor(s) are not influenced one way or another by knowing which patients received the device. You will be told if you received the ROX Coupler after all patients have been followed for a period of one year.

Randomized Control Group

All study patients will have the same visits and check-ups during the study.

Trial Duration

All patients will be seen by the study doctor and care team for at least one year from the date of randomization.

Medications

Before starting the ROX trial, you and your doctor will decide on a stable medication level that you can maintain throughout the one-year study. It is possible that a decrease or increase in your blood pressure may require a change in medication level. Any changes in medication should only be made after talking to your study care team. This is to ensure your safety and the integrity of the study.

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controlhtn2About the Clinical Study