ROX Medical has completed enrollment in its CONTROL-HTN trial, an international multi center, prospective, randomized, controlled, blinded endpoint trial of the ROX Coupler for the treatment of arterial hypertension.
Blood pressure reducing therapies have been in the headlines throughout 2014, ever since Medtronic’s renal denervation Symplicity HTN-3 study hit the rocks. Rox Medical’s approach is not a million miles away from renal denervation in that it aims to reduce BP by physical means. However, rather than dropping pressure by fiddling with the sympathetic nervous system, it effectively tricks the peripheral arteries by diverting some arterial blood, by means of the ROX coupler, directly from the iliac artery and iliac vein in the upper leg. This flow diversion has the combined effect of reducing blood pressure in the peripheral vasculature and simultaneously increasing arterial compliance.
The so-called FLOW procedure is minimally invasive, takes under one-hour, and is intended to be performed by interventional cardiologists, radiologists and vascular surgeons.
The CONTROL-HTN trial is evaluating the safety and efficacy of a percutaneous procedure creating a fixed connection between a central artery and vein in the upper leg – for the treatment of hypertension. The primary outcomes are the safety and efficacy of the ROX Coupler in reduction of ambulatory and office blood pressure at 6 months post procedure.
We covered the start of the trial when the company announced a first patient at St. Barts Hospital in London a year ago.
Now the study is fully enrolled and the company’s Chief Scientific Officer, Paul A. Sobotka, MD, anticipates that last data will be obtained and results presented later this year. Given the controlled and more importantly blinded nature of the study, albeit without the sham element, it should provide an interesting parallel with the HTN-3 renal denervation trial.
“We are very pleased with the continued strong interest in the ROX procedure to increase the choices available to patients and physicians for the treatment of hypertension,” commented ROX CEO Rodney Brenneman, “the immediately evident effects of the ROX treatment are gratifying to both the patient and interventional physician, and we are optimistic that this trial will demonstrate a durable and safe means of reducing blood pressure. The benefits of device mediated blood pressure therapy are obvious for patients unable or unwilling to sustain life long poly-pharmacy, and provide an absolutely unique and novel treatment strategy for severe hypertension.”
Source: Rox Medical, PR Newswire