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Objective Percutaneous transmural arterial bypass (PTAB) using the DETOUR System aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery (SFA) disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison to pre-established performance goals. Methods The DETOUR-2 IDE study is a prospective, single-arm, multi-center, international trial of symptomatic peripheral arterial disease patients (Rutherford Class 3-5) undergoing the DETOUR procedure for long-segment (>20cm) SFA disease. Pre-specified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization at 1-year. Results 202 patients were enrolled at 32 sites with 200 treated with the DETOUR System. The mean lesion length was 32.7cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety endpoint was met with a 30-day freedom from MAE rate of 93.0%. The 1-year primary effectiveness endpoint was met with 72.1% primary patency at 12 months. Primary assisted and secondary patency were 77.7% and 89% respectively at 12 months. The 12 month deep venous thrombosis (DVT) incidence was 4.1% with no pulmonary emboli (PE) reported. Venous quality of life scores showed no significant changes from baseline. There was a Rutherford improvement of at least ≥ 1 class through 12 months in 97.2% of patients. Mean ankle brachial index (ABI) also improved from 0.61 to 0.95 during this period. There were marked improvements in quality of life and functional status measures. Conclusions The DETOUR-2 study met both the primary safety and effectiveness endpoints, demonstrating clinical utility of this novel therapeutic strategy in long femoropopliteal lesions.
Lyden et al. (Thu,) studied this question.