US-based ROX Medical has completed the patient enrollment in CONTROL-HTN trial, an international multi centre, prospective, randomised, controlled, blinded endpoint trial designed to assess ROX Coupler in patients with arterial hypertension.
The NCT01642498 trial is designed to evaluate the safety and efficacy of a percutaneous procedure creating a fixed connection between a central artery and vein in the upper leg for treatment of hypertension.
The primary outcomes are the safety and efficacy of the ROX Coupler in reduction of ambulatory and office blood pressure at six months post procedure.
ROX Medical chief scientific officer Dr Paul Sobotka anticipates that last data obtained and results to be presented in the fall of 2014.
ROX Medical's FLOW procedure is a relatively painless minimally invasive, under one-hour, straight forward and catheter based procedure to place a small coupler between the artery and vein in the upper leg.
The procedure reduces peripheral vascular resistance, holding the promise of a meaningful long-term reduction in hypertension.
Uniquely, the FLOW procedure only involves the vascular structure, has an immediate effect; and is fully reversible.
The procedure is performed by interventional cardiologists, radiologists and vascular surgeons.
ROX CEO Rodney Brenneman said the company is pleased with the continued strong interest in the ROX procedure to increase the choices available to patients and physicians for treatment of hypertension.
"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," Brenneman said.
"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."
According to the company, the ROX FLOW procedure for hypertension is not approved for use in the US.
Image: The ROX FLOW procedure for hypertension is not approved for use in the US. Photo: courtesy of BusinessWire/ ROX Medical, Inc.