Endologix DETOUR2 Trial’s 1-Year Results Published

May 13, 2024—Endologix LLC announced the publication of the 1-year results of the DETOUR2 trial. The study is a prospective, single-arm, international, multicenter clinical evaluation of the company’s Detour system for fully percutaneous femoropopliteal bypass procedures.

According to Endologix, the findings demonstrated that percutaneous transmural arterial bypass (PTAB) with the Detour system is a viable endovascular option for patients with long-segment, complex superficial femoral artery (SFA) disease. The procedure uses the vein as a conduit to bypass the SFA.

Sean P. Lyden, MD, et al published the results, which are available online in Journal of Vascular Surgery. 

As summarized in the Endologix press release, the DETOUR2 study enrolled 202 patients at 32 sites, and 200 patients were treated with the Detour system. Lesion characteristics included: mean length was 32.7 cm; 96% were chronic total occlusions; and 70% were severely calcified.

The investigators reported low rates of complications, deep venous thrombosis (DVT), and clinically driven target lesion revascularization (CD-TLR), along with excellent 1-year primary patency.

Through 1 year, the study showed 87.7% freedom from CD-TLR; 92.4% patency, defined as freedom from occlusion, expressed as a binary endpoint; 97.2% clinical success, defined as improvement of at least one Rutherford category; and 4.1% incidence of symptomatic DVT with no reported pulmonary emboli. Additionally, the rate of major procedure-related infection within 30 days after the index procedure was 0.5%; the freedom from major adverse events at 30 days was 93%; and the average length of hospital stay was 1.1 days.

In July 2023, Endologix announced the commencement of a targeted market release of the Detour system for PTAB in the United States. FDA approval was announced in June 2023.

In February 2024, the company announced the initiation of a postmarket study to evaluate the real-world performance of the Detour system.

“The publication of the 1-year results confirms the Detour system’s clinical promise in treating long femoropopliteal lesions,” stated Endologix President and CEO Matt Thompson, MD, in the company’s press release. “As we launch this therapy, we are committed to an extensive training and education program that ensures the best patient outcomes. Consistent with our evidence-based approach, further data on the performance of the Detour system in real-world use will be defined in the PTAB-1 postmarket study.”