Eighteen-Month Results of the DETOUR I Trial Presented for PQ Bypass' Detour System

November 6, 2018—Eighteen-month preliminary results from the DETOUR I trial were presented by Ehrin Armstrong, MD, at VIVA 18, the Vascular Interventional Advances, conference held November 5–8 in Las Vegas, Nevada. Dr. Armstrong is Associate Professor of Cardiology at the University of Colorado.

The DETOUR I trial was designed to evaluate the safety and effectiveness of the Detour procedure for percutaneous femoropopliteal bypass. Percutaneous femoropopliteal bypass is achieved using the PQ Detour system (PQ Bypass), including a specialized crossing device, radiopaque snare, and the Torus stent graft. When used in combination, these tools create a path for arterial flow originating in the superficial femoral artery, which then travels through the femoral vein and re-enters in the popliteal artery at the site of reconstitution.

DETOUR I is a prospective, single-arm, multicenter study that enrolled 77 patients and 81 limbs across Europe, New Zealand, and Chile. Inclusion criteria for this clinical evaluation required de novo, in-stent restenotic, or chronic total occlusion lesions that were ≥ 10 cm in length, as well as a femoral vein with a diameter of ≥ 10 mm or the presence of a duplicate femoral vein. Follow-up visits occurred at 30 days, and 3, 6, 12, and 18 months, and will continue through 36 months. Independent review of the data is performed by the Cleveland Clinic core lab and Syntactx clinical events committee at key evaluation points.

Results of the study at 12 months were presented at the Society for Vascular Surgery meeting in June 2018. At 18 months, average lesion length was 37 cm, rate of primary patency was 67.6%, freedom from death was 98.5%, freedom from amputation was 98.6%, and freedom from target lesion revascularization was 74.6%. Rutherford improvement ≥ 1 class was seen in 98.5% of limbs, and ≥ 2 classes in 94%. Additional data evaluating the safety and effectiveness of the Detour procedure will be collected through 36-month follow-up in the DETOUR I trial, and in the DETOUR II United States investigational device exemption study, which is currently enrolling patients. The Detour procedure earned CE Mark approval in February 2017.