REALITY Trial Begins for Medtronic’s Directional Atherectomy and Drug-Coated Balloon in PAD Treatment

Domingo 7 de Agosto del 2016

Medtronic plc and VIVA Physicians announced that the first patient was enrolled in the REALITY study. The study is assessing outcomes for patients with significantly calcified and symptomatic femoropopliteal peripheral artery disease (PAD) after adjunctive use of directional atherectomy and drug-coated balloon (DCB). The study is sponsored and managed by VIVA Physicians with support from Medtronic through an external research project grant.

According to Medtronic and VIVA Physicians, the REALITY study is evaluating patient outcomes with adjunctive use of the HawkOne or TurboHawk atherectomy systems and the In.Pact Admiral DCB.

The multicenter, 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. 

The study’s coprincipal investigators are Krishna Rocha-Singh, MD, and Brian DeRubertis, MD. Dr. Rocha-Singh is Chief Scientific Officer of Prairie Heart Institute of Illinois in Springfield, Illinois. Dr. DeRubertis is Associate Professor of Surgery at UCLA Division of Vascular Surgery in Los Angeles, California. The study will include investigative sites in the United States and Germany.

In the Medtronic and VIVA Physicians press release, Dr. Rocha-Singh commented, “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. 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, treated the first patient enrolled in the study. Dr. Gammon, who is an interventional cardiologist at Austin Heart Central-Heart Hospital in Austin, Texas, stated in the announcement, “We know that directional atherectomy and DCB perform well as standalone treatments, and early data suggest 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.”