Endologix DETOUR-2 Study’s 1-Year Safety and Effectiveness Data Presented

November 3, 2022—One-year outcomes were presented from the DETOUR 2 trial, which is a prospective, single-arm, multicenter, international clinical investigation evaluating the safety and effectiveness of the Detour system (Endologix).

The Detour system allows the creation of a fully percutaneous femoropopliteal bypass that is routed through the femoral vein, allowing an endovascular approach to traditional surgical procedures. The Endologix Detour system uses the company’s EndoCross device and Torus stent graft to treat patients with moderate to severe peripheral artery disease with long blockages of the superficial femoral artery (SFA). On October 10, the company announced the submission of a premarket approval (PMA) application seeking FDA approval for the device.

Sean Lyden, MD, presented the data in the first of three Late-Breaking Clinical Trials sessions at the VIVA Foundation’s VIVA22 conference held October 31 to November 3 in Las Vegas, Nevada.

According to the VIVA Foundation press release, a total of 220 patients were enrolled at 36 investigational centers in the United States and Europe. Eligible patients had symptomatic lesions ≥ 20 cm, chronic total occlusions (CTOs), or a ≥ 70% lesion including de novo, restenotic, or in-stent restenosis. Follow-up occurred at 1, 6, 12, 24, and 36 months postprocedure.

Patient characteristics included a mean age of 68.9 years, and 73.8% were men. Baseline comorbidities were hypertension (87.6%; 177/202), diabetes (34.7%; 70/202), renal insufficiency (10.9%; 22/202), and coronary artery disease (46.0%; 92/200). The most frequent Rutherford category was category 3 (77.7%; 157/202), and the average ankle-brachial index was 0.60 ± 0.21.

Baseline lesion characteristics included CTO (96.0%; 194/202), diffuse stenosis > 70% (97.0%; 196/202), and severe calcification (70.4%; 126/179). The mean lesion length was 327 ± 61 mm and mean CTO length was 217 ± 86 mm.

The primary safety endpoint was freedom from major adverse events (MAEs) at 30 days. MAEs included death, clinically driven target lesion revascularization (CD-TLR), amputation of the treated limb, symptomatic deep vein thrombosis, pulmonary embolism, and procedure-related bleeding requiring transfusion of packed red blood cells or surgery.

Dr. Lyden reported that freedom from MAEs at 30 days was 93.0% (185/199). The primary effectiveness endpoint is patency at 12 months postprocedure. Patency is defined as the absence of CD-TLR and absence of recurrent target lesion diameter stenosis > 50%.

Dr. Lyden reported that patency at 12 months was 68.1% (128/188). The Kaplan-Meier estimate of CD-TLR and absence of recurrent target lesion diameter stenosis > 50% at 12 months was 72.1%.

The investigators found that the lower one-sided CI was above the performance goal, indicating that the prespecified primary safety and effectiveness endpoints were met, stated the VIVA Foundation press release.