One year outcome after primary stenting of infrapopliteal lesions with the CHROMIS DEEP stent in the management of critical limb ischaemia

Abstract

The study investigates the safety and efficacy of primary stenting of infrapopliteal lesions using the Chromis Deep stent (Invatec, Roncadelle, Italy) in patients presenting with critical limb ischaemia (CLI). Fifty patients with infrapopliteal arterial occlusive disease were included in the study from March until November 2007. All patients presented with CLI, 42 (84.0%) and 8 (16.0%) were diagnosed as Rutherford class 4 and 5, respectively. Procedural success was achieved in all 50 patients. Fifty study lesions were treated with angioplasty using the Amphirion Deep balloon and followed by the insertion of 58 Chromis Deep stents. After intervention patients were followed at 1, 6 and 12 month intervals with clinical examination and arterial duplex study. The survival of the studied population was 79.8%, the limb salvage was 91.5% and primary patency of treated vessel was 52.9% at 12 months. Primary stenting using the balloon-expandable Chromis Deep stent in combination with the Amphirion Deep balloon is a safe treatment strategy for infrapopliteal lesions in patients with CLI.