Trial of DCB, atherectomy in patients with calcified femoropopliteal lesions launched

Medtronic and VIVA Physicians announced the enrollment of the first patient in the REALITY study of patients with severely calcified lesions in the femoropopliteal artery.

The trial will gauge outcomes for patients with significantly calcified and symptomatic femoropopliteal peripheral artery disease following adjunctive use of directional atherectomy (TurboHawk, Medtronic) and a drug-coated balloon (IN.PACT Admiral, Medtronic), according to a press release issued by Medtronic.

The prospective, single-arm study will enroll as many as 250 patients at up to 15 sites and will employ angiographic and duplex ultrasound core lab adjudication. According to the release, primary patency will be measured by duplex ultrasound at 12 months, and patients will be followed-up over 24 months to assess clinically driven target lesion revascularization.

Krishna Rocha-Singh, MD, chief scientific officer at Prairie Heart Institute of Illinois, and Brian DeRubertis, MD, FACS, associate professor of surgery at the UCLA Division of Vascular Surgery, were named co-principal investigators.

“The severity of [PAD] can often have an impact on treatment options,” Rocha-Singh said in the release. “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.”

Disclosure: Rocha-Singh reports consulting for Medtronic.