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.
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.
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.
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.