Durability of Percutaneous Bypass for Treatment of Femoropopliteal Disease: Two-year Outcomes of the DETOUR-2 Study

The DETOUR System is a novel percutaneous femoropopliteal bypass-like procedure for PAD patients with complex disease including long lesions, heavy calcification, and chronic total occlusions. Detour system uses standard endovascular techniques crossing device stent graft to create bypass. We report two-year safety effectiveness results of this innovative revascularization. DETOUR-2 IDE study prospective, single-arm, multicenter center trial across 36 sites lesions >20 cm in the segment Rutherford Stage 3 5 disease. Follow-up visits were conducted at 30 days, 6 months, annually through years. primary end point was freedom from major adverse events days. patency 12 months (absence clinically driven target lesion revascularization [CD-TLR] recurrent diameter stenosis >50%). 24-month assessments include composed mortality, CD-TLR, index limb amputation venous events. enrolled 202 treated System; 96% had occlusion. Mean length 327 ± 61 mm. Primary clinical success rate 2 years 94.9%. Primary-assisted 24 68.8%. CD-TLR 24.5%. At years, 1.6%. All-cause mortality 5.1%. Occurrence deep vein thrombosis pulmonary embolism 4.1% 0%, respectively. Overall Villalta scores decreased (−0.9 3.45), while Venous Clinical Severity Score parameters largely remained unchanged follow-up. outcomes demonstrate durable treatment effect utility therapeutic strategy lesions. These longer-term suggest that bypass safe acceptable option symptomatic peripheral artery similar open surgical prosthetic