Ireland-based medical technology firm Medtronic has started the REALITY study to evaluate the use of directional atherectomy and drug coated balloons in patients with peripheral arterial disease (PAD).
Directional atherectomy and drug coated balloons to treat long, calcified femoropopliteal artery stenoses (REALITY) will evaluate 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 company's directional atherectomy systems and IN.PACT Admiral drug coated balloon will be evaluated.
A total of 250 subjects will be enrolled in the multi-centre, prospective, single-arm observational angiographic and duplex ultrasound core lab adjudicated study at up to 20 sites in the US, with primary patency evaluated by duplex ultrasound at 12 months.
In the study, patients will be followed for 24 months to determine CD-TLR. It also comprises core lab adjudicated sub-analyses, including intravascular ultrasound assessment of the efficiency of directional atherectomy to debulk various plaque morphologies.
Analyses include the assessment of severe calcium in long lesions prior to DCB deployment and 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.
St John's Hospital Prairie Heart Institute chief scientific officer Dr Krishna Rocha-Singh said: "As standalone treatments for peripheral arterial disease, directional atherectomy and DCBs have demonstrated strong clinical results.
"However, challenges in treating long and severely calcified femoropopliteal lesions remain, including the associated provisional stent rate with DCB and reintervention rates with directional atherectomy over the long term.
"The REALITY study was driven by the need to look at a viable treatment paradigm that combines the use of directional atherectomy and DCB therapy to address these challenges."
In addition, a health economics and quality of life assessment will be included in 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 randomised pilot study to determine the outcome differences between patients who were treated with directional atherectomy and DCB and DCB alone."
The company also announced new clinical data in interventional treatments for aortic and peripheral vascular diseases at Vascular Interventional Advances (VIVA) 2015.
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.