ACOART‐BTK.

Trial name or title	Evaluation of the Use of ACOTEC Drug‐Eluting Balloon Litos in Below‐The‐Knee Arteries to Treat Critical Limb Ischemia (ACOART‐BTK).
Methods	Randomized controlled trial
Participants	Country: Italy Setting: single hospital Number of participants: 140 Inclusion Criteria: Age > 18 years CLI (Rutherford class 4 to 6) Angiographic stenosis > 50% or occlusion of at least 1 tibial vessel of at least 40 mm for which an intervention treatment is scheduled Exclusion criteria: Need for major amputation known before intervention Allergy to paclitaxel Contraindication for combined antiplatelet treatment Life expectancy < 1 year Hypersensitivity or contraindication to 1 of the study drugs Lack of consent
Interventions	Uncoated balloon angioplasty device: unspecified conventional balloon catheter DEB device: Litos drug‐eluting balloon catheter Vessels treated: infrapopliteal arteries
Outcomes	Primary: Angiographic late lumen loss at 6 months Secondary: Angiographic binary restenosis at 12 months TLR at 12 months
Starting date	September 2015
Contact information	Dr Leonardo Bolognese, l.bolognese@usl8.toscana.it
Notes	Sponsor: Ospedale San Donato No industry support declared