Avinger has begun enrolling patients into the CONNECT trial, a prospective, multicenter, non-randomized trial that will assess its Wildcat Catheter’s ability to cross chronic total occlusions (CTO) in femoropopliteal lesions in patients with peripheral artery disease.
The first patient was enrolled at St. John Hospital, a member of St. John Providence Health and the St. John Providence Health Heart Care Network in Detroit.
According to Redwood City, Calif.-based Avinger, the device crosses CTOs by creating a channel through the blockage using a retractable spiral wedge to treat lesions and lead to the long-term treatment of PAD.
The CONNECT (Chronic Total OcclusioN CrossiNg with thE WildCat CatheTer) trial will assess 88 PAD patients with femoropopliteal CTO lesions at 15 U.S. centers.
The Wildcat catheter gained FDA 510(k) clearance in February 2009 as a guidewire support device; however, Avinger is conducting the CONNECT trial to gain FDA clearance for an indications of crossing CTOs.