Twelve-Month Data Presented for PQ Bypass' Detour System
June 28, 2018—PQ Bypass, Inc. announced that results from the DETOUR I trial evaluating the company's Detour system for percutaneous femoropopliteal bypass were presented as a late-breaking clinical trial session at the Society for Vascular Surgery's Vascular Annual Meeting held June 20–23 in Boston, Massachusetts.
According to the company, the DETOUR results showed promising 12-month durability for patients with extremely long blockages in the superficial femoral artery (SFA). The trial evaluated long and complex lesions: the average lesion length was 37 cm, 100% were TASC II C and D, 96% were chronic total occlusions, and 81% had moderate to severe calcification.
The DETOUR I trial is a prospective, single-arm, multicenter, core lab–adjudicated study. The trial enrolled and treated 77 patients and 81 lesions. Primary and primary-assisted patency at 12 months in all lesions of the DETOUR I trial were 73% and 80%, respectively. Secondary patency was achieved in 94% of patients. Additional safety and effectiveness outcomes include 100% freedom from amputation, 99% freedom from acute limb ischemia, and Rutherford improvement of two or more classes in 90% of patients.
In the company's announcement, Dainis Krieviņš, MD, commented, “The lesions treated in DETOUR I were more than just long, they were extremely long, completely blocked, and severely calcified. Endovascular devices currently approved for use on these incredibly challenging lesions have surprisingly low durability in lesions that are half the size of the average DETOUR lesion and fail approximately 40% of the time by the 12-month milestone. This truly highlights the need for the minimally invasive Detour procedure for long, complex SFA lesions.” Dr. Krieviņš is a vascular surgeon and Director of the Institute of Research at Pauls Stradins Clinical University Hospital in Riga, Latvia.
PQ Bypass advised that the Detour system is limited to investigational use only in the United States. The company received European CE Mark approval for the Detour system in March 2017. The pivotal DETOUR II trial is currently being conducted in the United States and will enroll up to 292 patients at up to 40 sites across the United States and Europe.