Researchers recently reported positive 12-month data for the DETOUR I Trial, which assessed the PQ Bypass DETOUR System for percutaneous bypass. The study found that the PQ DETOUR procedure is safe and effective at 12 months in patients with long superficial femoral artery (SFA) lesions. The recent data were presented in a late-breaking clinical trial session at the Society for Vascular Surgery Annual Meeting in Boston, Massachusetts.
The DETOUR procedure is a percutaneous femoropopliteal bypass that uses the PQ Bypass’ proprietary stent grafts to create a pathway that travels through the femoral vein and bypasses the diseased section of the artery. The average lesion length of patients enrolled in the trial was 37 cm, with 100% TASC II C/D, 96% chronic total occlusions (CTO), and 81% with moderate-to-severe calcification. Patients had a mean ankle-brachial index of 0.64, and 92.2% of patients were Rutherford class 3.
“The lesions treated in DETOUR I were more than just long, they were extremely long, completely blocked, and severely calcified,” said Dainis Krieviņš, MD, PhD, vascular surgeon and Director of the Institute of Research at Pauls Stradins Clinical University Hospital.
The DETOUR I trial is a prospective, single-arm, multicenter study that included 77 patients with 81 lesions. At 12 months, the primary patency in all lesions was 73%, while the primary-assisted patency was 80%. Ninety-four percent of patients reached secondary patency, all patients were free from amputation, and 99% did not have acute limb ischemia. In 90% of patients, there was a Rutherford improvement of 2 or more classes at 12 months. Additionally, the mean ankle-brachial index was better in the 12-month time frame (0.92) than before the procedure. There was a technical success rate of 98.8% for the procedure, the researchers noted.
Although the DETOUR system received a CE mark for commercial use in Europe in February 2017, it is not currently commercially approved in the United State. At this time, the researchers have an investigational device exemption and are enrolling patients in the DETOUR II trial.
PQ Bypass Reports Positive 12-Month Results for Entirely New Procedure to Treat Extremely Long SFA Lesions in Patients with PAD. Press Release. June 28, 2018. https://www.businesswire.com/news/home/20180628005470/en/