Frequently Asked Questions

If you have been diagnosed with uncontrolled high blood pressure, you may be a candidate for participation in a clinical study sponsored by ROX Medical. The goal of the study is to determine if the ROX Coupler safely lowers blood pressure and helps patients control their hypertension. The following list of Frequently Asked Questions (FAQ) is intended help you understand the ROX therapy and clinical trial. The information provided in this FAQ is not a substitute for information provided by your physician(s).

Review the ROX CONTROL HTN-2 Trial Patient Guide Am I ELIGIBLE for the ROX CONTROL HTN-2 trial?

Watch the video to learn more about Hypertension and the Control HTN 2 Trial

Blood pressure is defined by two numbers, systolic and diastolic:
Systolic– blood pressure in the arteries as you heart beats (upper number)
Diastolic– blood pressure in the arteries between heartbeats (lower number)

Blood pressure is the measure of force with which blood moves through the body, and the pressure it creates against the artery walls. Normally blood pressure rises and falls throughout the day.  If it stays high, you are forcing your heart to work beyond its capacity.

High blood pressure raises your risk for heart disease and stroke, which are the leading cause of death in the United States.*

*American Heart Association

According to the American Heart Association*, blood pressure is classified as

  • Normal when systolic pressure is below 120 and diastolic pressure is below 80 mmHg
  • Prehypertension when systolic pressure is 120-139 or diastolic pressure is 80-89 mmHg
  • Hypertension when systolic pressure is above 140 or diastolic pressure is above 90 mmHg

*American Heart Association

As blood pressure increases, the risks of stroke, heart attack, heart failure and kidney failure also increase. Lowering blood pressure even a small amount reduces that risk. A recent study showed that for every 1 mmHg reduction of blood pressure the relative risk of cardiovascular disease and death is reduced by 2%. So, reducing your blood pressure by 15 mmHg could reduce your risk of cardiovascular disease or death by 30%.*

*The SPRINT Research Group. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med 2015 Nov 26.

While there is no cure for hypertension, there are steps you can take to reduce high blood pressure. Lifestyle changes such as eating a low-salt diet, exercising, and maintaining a healthy body weight may lower your blood pressure.

Many patients require life-long blood pressure medications to treat high blood pressure.

Often, patients need to take two, three, or more medications. Like all medications, blood pressure medications may have uncomfortable side effects. Some side effects can be severe. Be sure to talk with your doctor to understand the benefits and risks of medications.

Sometimes blood pressure remains high despite diet, exercise, and taking three or more medications. This is called “uncontrolled hypertension.”

The ROX Coupler is a small implantable device that creates a passage (called an anastomosis) between an artery and a vein in your pelvis. This passageway allows a small amount of blood to flow from the artery to the vein. Since the blood in the artery is at a higher pressure than the blood in the vein, most patients will experience an immediate reduction in blood pressure.

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.

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.*
* Lobo et al, 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. The Lancet. 2015 Apr 25;385(9978):1634-41.

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 you.

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.

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.

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.

All study patients will have the same visits and check-ups during the study. If the study shows the Coupler safely lowers blood pressure, ROX Medical will work with the FDA to make the device available to study patients who were randomized to the control group. Your study doctor will keep you informed throughout the trial.

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

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.

Your study doctor will keep all personal identifiers (name, address, contact information) strictly confidential. The data collected from your participation will only be identified by a code number (such as patient 100-001). This is required by the US Food and Drug Administration for all clinical studies since patient privacy is important.

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.

All eligible patients will undergo a screening period involving three visits to the study doctor’s office. At each visit, your care team will measure blood pressure and perform diagnostic tests including blood work. These visits will help the care team determine whether you are a candidate for the study. One important test includes wearing an ambulatory blood pressure monitor. The monitor, which is worn on the upper arm, measures blood pressure continuously over a 24-hour period.

On the day of the procedure, at the hospital, your care team will monitor your blood pressure before, during, and after the procedure.

During the procedure, the doctor will first evaluate your heart function. This test is called a right heart catheterization. Next, the study doctor will x-ray the artery and vein where the Coupler would be placed. If all study criteria are met, you will then be randomized. Half of the patients will receive the Coupler and half will not. Your care team will provide you with headphones and eye covers to prevent you from knowing which group you have been assigned to. The entire procedure should take less than an hour. You will stay overnight in the hospital.

The day after your procedure, your study care team will evaluate your needle punctures, take your blood pressure, and you will be discharged to go home. You will be instructed to take your blood pressure medications. It is possible that a change in medications is needed. You will also be given compression stockings to wear daily.

You must be able to return to your study doctor for follow-up visits at 1 week, 1 month, 3 months, 6 months and 1 year after the procedure for an examination. The 6-month visit is very important. Data collected at 6-months, especially from ambulatory blood pressure monitoring, will be used to establish if the ROX Coupler lowered blood pressure.

The overall goal of this trial is to determine if the ROX Coupler can safely lower your blood pressure beyond that of your current medication therapy. It is therefore very important that if you commit to participating in the trial,  you must also commit to continuing to take your prescribed medications throughout the trial. You will be closely followed by experts in treating hypertension and they will adjust your medicines as needed. For your own safety, you should follow your doctor’s instructions regarding taking blood pressure medications.

Ambulatory Blood Pressure  (ABP) measures blood pressure at regular intervals. It is believed to be able to reduce the white coat hypertension effect in which a patient’s blood pressure is elevated during the examination process due to nervousness and anxiety caused by being in a clinical setting.

Anastomosis
– The connection or passageway of normally separate parts. Connecting two blood vessels.

Cardiovascular Disease – Heart and blood vessel disease, conditions that involve narrowed or blocked blood vessels that can lead to a heart attack, chest pain (angina) or stroke. Diseases under the heart disease umbrella include blood vessel diseases, such as coronary artery disease; heart rhythm problems (arrhythmias); and heart defects you’re born with (congenital heart defects).

Catheter
– A tubular medical device for insertion into canals, vessels, passageways, or body cavities for diagnostic or therapeutic purposes.

Hypertension/High Blood Pressure – A common condition in which the long-term force of the blood against your artery walls is higher than normal, enough that it may eventually cause health problems, such as heart disease.

Interventional Procedure – A  treatment that involves making small  cut or a hole to gain access to the inside of a patient’s body – for example, inserting a tube into a blood vessel.

Percutaneously – The passage through the skin by needle puncture, including introduction of wires and catheters.

controlhtn2Frequently Asked Questions