Objectives: The objective of the DETOUR 2 trial was to investigate the safety and effectiveness of the PQ Bypass System by comparing the primary safety and effectiveness results to pre-established performance goals. Herein, we report the 12 month study results.
Methods: DETOUR 2 is a prospective, multi-center, single-arm trial conducted at 36 sites in the United States and Europe. The primary safety endpoint is freedom from a major adverse event (MAE) at 30 days, defined as death, clinically driven target lesion revascularization (CD-TLR), amputation of the treated limb, symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), or procedure-related bleeding requiring any transfusion of packed red blood cells (PRBC) or surgery. The primary efficacy endpoint is defined as an absence of CD-TLR and absence of recurrent target lesion diameter stenosis >50% by imaging (e.g., duplex ultrasound peak systolic velocity ratio of >2.5 or invasive angiography) within the stent or immediately 1 cm above or below the treated segment at 12-months. Patients are followed for 36 months after the index procedure.
Results: 202 patients have been enrolled and treated. The mean age of all enrolled patients is 69 ± 9.37 years, and 73% were male. Core-lab assessed angiography indicate a mean lesion length of 32.7 ± 6.12cm, a 70% of lesions had severe calcification, and 95% lesions were considered to be Chronic Total Occlusions. An analysis of the subjects that have returned for follow up has been performed. The primary safety endpoint has been met. Current trends of the effectiveness endpoint are supportive of the therapy. Additional follow-up will allow for formal evaluation of this endpoint with core-lab and adjudicated data.
Conclusions: Percutaneous femoropopliteal bypass using the femoral vein as a conduit is a new alternative for the treatment of long-segment disease. 12 month effective results provide a broader view of a minimally invasive approach with the PQ Bypass System.
