Medtronic plc (NYSE:MDT) and VIVA Physicians today report the first patient enrolled in the REALITY Study. The VIVA sponsored study is assessing outcomes for patients with significantly calcified and symptomatic femoropopliteal peripheral artery disease (PAD), following adjunctive use of directional atherectomy and drug-coated balloon (DCB). Krishna Rocha-Singh, MD, chief scientific officer, Prairie Heart Institute of Illinois, and Brian DeRubertis, MD, FACS, associate professor of surgery, UCLA Division of Vascular Surgery, are co-principal investigators. The study will include investigative sites both within the U.S. and in Germany.
"PAD is a complex and progressive disease. The severity of the disease can often have an impact on treatment options for patients. Long lesion length and severe calcification are obstacles that challenge both our ability to gain acute luminal gain and to maintain long-term patency," said Dr. Rocha-Singh. "REALITY is driven by the need to look at a viable treatment paradigm that combines the use of directional atherectomy and DCB therapy to address the challenges of treating complex PAD."
Roger Gammon, MD, interventional cardiologist at Austin Heart Central-Heart Hospital, treated the first patient enrolled in the study. "We know that directional atherectomy and DCB perform well as standalone treatments; and early data suggests that combined therapy may improve patient outcomes in more complex lesions. Through REALITY we hope to answer this critical question with rigorous clinical data in this well designed study," said Dr. Gammon.
The REALITY Study evaluates patient outcomes with adjunctive use of Medtronic HawkOne or Medtronic TurboHawk and Medtronic IN.PACT Admiral drug-coated balloon. The multi-center, international, prospective, single-arm study will enroll up to 250 subjects at up to 15 sites. The study includes angiographic and duplex ultrasound core lab adjudication. Primary patency is assessed by duplex ultrasound at 12 months. Patients are followed up to 24 months to determine clinically driven target lesion revascularization (CD-TLR). The study is sponsored and managed by VIVA Physicians with support from Medtronic through an external research project grant.
"Medtronic is committed to improving patient lives through unique clinical partnerships, exemplified by the REALITY Study," said Mark Pacyna, vice president and general manager of the Peripheral business, which is part of the Aortic & Peripheral Vascular division at Medtronic. "This study is designed to further refine the PAD treatment algorithm by providing greater evidence for vessel preparation with directional atherectomy prior to treatment with DCB."