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Aortouniiliac stent grafts allow the endovascular treatment of complex anatomy aortoiliac aneurysms. The main drawback is the need for femoro-femoral crossover bypass, with its complications and its patency limitations. However, some authors have shown good results of femoro-femoral crossover bypass in aneurysmal disease. In this article, initial and long-term results of our experience in femoro-femoral crossover bypass revascularization after endovascular aortouniiliac stent grafts repair of aortoiliac aneurysms is reported. Prospective collection, intention-to-treat, and retrospective analysis maintained database. Femoro-femoral crossover bypass patency assessment of all patients treated between January 1999 and September 2002, compared patients with or without associated occlusive arterial disease. Urgent indications were excluded. In total of 52 patients, with a mean age 72.6 years, 30.8% of patients were identified with associated occlusive arterial disease. Initial systemic and local, access site, complications were 7.7% and 7.7%, respectively, no early thrombosis or death is reported. Primary patency was 90.9% at 54 months, 66 months assisted primary and secondary patency were 97.7% and 100%, respectively. The 48-month survival rate was 84.2%. No significant differences between patients with or without associated occlusive arterial disease were found. Femoro-femoral crossover bypass after aortouniiliac stent grafts treatment of aortoiliac aneurysms shows excellent initial and long-term patency and low complication rate.

Background Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatment, based on antiplatelet therapy and statins, has demonstrated deficient improvement of the disease. In recent years, research has shown that it is possible to improve tissue perfusion through therapeutic angiogenesis. Both in animal models and humans, it has been shown that cell therapy can induce therapeutic angiogenesis, making mesenchymal stromal cell-based therapy one of the most promising therapeutic alternatives. The aim of this study is to evaluate the feasibility, safety, and efficacy of cell therapy based on mesenchymal stromal cells derived from adipose tissue intramuscular administration to patients with type 2 diabetes mellitus with critical limb ischemia and without possibility of revascularization. Methods A multicenter, randomized double-blind, placebo-controlled trial has been designed. Ninety eligible patients will be randomly assigned at a ratio 1:1:1 to one of the following: control group (n = 30), low-cell dose treatment group (n = 30), and high-cell dose treatment group (n = 30). Treatment will be administered in a single-dose way and patients will be followed for 12 months. Primary outcome (safety) will be evaluated by measuring the rate of adverse events within the study period. Secondary outcomes (efficacy) will be measured by assessing clinical, analytical, and imaging-test parameters. Tertiary outcome (quality of life) will be evaluated with SF-12 and VascuQol-6 scales. Discussion Chronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future. Trial registration ClinicalTrials.govNCT04466007. Registered on January 07, 2020. All items from the World Health Organization Trial Registration Data Set are included within the body of the protocol.

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