Results from the DETOUR I trial evaluating the DETOUR System (PQ Bypass) for percutaneous bypass showed promising 12-month durability for patients with extremely long blockages in the superficial femoral artery (SFA). The data were presented as a late-breaking clinical trial session last week at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (20–23 June, Boston, USA).
The trial enrolled lesions longer and more complex than those typically studied in SFA clinical trials, with an average lesion length of 37cm, 100% TASC II C/D, 96% chronic total occlusions (CTO), and 81% with moderate-to-severe calcification.
The DETOUR I trial, a prospective, single-arm, multicentre, core lab-adjudicated study, enrolled and treated 77 patients and 81 lesions. Primary and primary-assisted patency at 12 months in all lesions of the DETOUR I trial was 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 ischaemia, and Rutherford improvement of ≥2 classes in 90% of patients.
“The lesions treated in DETOUR I were more than just long, they were extremely long, completely blocked, and severely calcified,” said Dainis Krieviņš, vascular surgeon and director of the Institute of Research at Pauls Stradins Clinical University Hospital. “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.”
Percutaneous femoropopliteal bypass (the DETOUR procedure) is an entirely new procedure enabled by the DETOUR System. The DETOUR procedure creates a pathway with PQ Bypass’s proprietary stent grafts, originating in the SFA, travelling through the femoral vein, and ending in the popliteal artery, bypassing the diseased part of the artery. The stent grafts re-direct oxygen-rich blood around the blockage, restoring blood flow to the lower leg and foot of the patient.
“These results represent exciting promise for patients with long, complex SFA lesions, a growing, yet severely underserved population,” said Heather Simonsen, VP of Global Therapy Development at PQ Bypass. “By routing blood around the disease, rather than forcing a way through it, the DETOUR System is designed to treat extremely long lesions that are not well-addressed by current endovascular devices. We look forward to continuing the collection of clinical data in our US IDE to build upon the outcomes observed in DETOUR I.”