Irish medical technology firm Medtronic has started the REALITY study to assess the use of directional atherectomy and drug coated balloon in patients with peripheral arterial disease (PAD).
The directional atherectomy + drug-coated Balloon to treat long, calcified femoropopliteal artery stenoses (REALITY) will assess patient outcomes following adjunctive use of directional atherectomy and DCB treatment of patients with symptomatic PAD in long, calcified lesions in the superficial femoral artery (SFA) or popliteal artery.
VIVA Physicians has sponsored and will manage the REALITY study, in which the Medtronic’s directional atherectomy systems and IN.PACT Admiral drug-coated balloon will be assessed.
The trial is a multi-center, prospective, single-arm observational angiographic and duplex ultrasound core lab adjudicated study, which will enroll around 250 subjects at up to 20 sites in the US, with primary patency evaluated by duplex ultrasound at 12-months.
In the trial, patients will be followed to 24 months to determine CD-TLR. It also comprises core lab adjudicated sub-analyses, including the intravascular ultrasound assessment of the efficiency of directional atherectomy to debulk various plaque morphologies.
The analyses include the assessment of severe calcium in long lesions prior to DCB deployment and the validation of the peripheral arterial calcium scoring scale (PACSS) to assess the impact of severe vessel calcification on major adverse clinical events (MACE) from the procedure through 12 months.
In addition, a health economics and quality of life assessment will be included under the study.
Medtronic cardiac and vascular group aortic and peripheral vascular business medical director Dr Mark Turco said: "DEFINITIVE AR was the first, and only randomized pilot study to determine the outcome differences between patients who were treated with directional atherectomy and DCB and DCB alone."
Medtronic has also announced new clinical data in interventional treatments for aortic and peripheral vascular diseases at Vascular Interventional Advances (VIVA) 2015.
The clinical data for the Valiant Captivia thoracic stent graft system for the treatment of complicated type B aortic dissection demonstrated continued safety and efficacy at two years.
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.