The TANGO trial is a prospective, multi-center, randomized, dose escalation study to document the effects of adventitial delivery of TORISEL® (temsirolimus) after revascularization of lesions below the knee in symptomatic patients with critical limb ischemia (CLI). Up to 60 patients (20 low-dose, 20 high-dose and 20 control) will be enrolled at up to 15 sites in the United States. This study will assess the safety and effectiveness of Bullfrog® Micro-Infusion Device adventitial deposition of temsirolimus in reducing intimal hyperplasia, inflammatory markers and composite safety endpoints in patients with clinical evidence of chronic critical limb ischemia after revascularization of one or more angiographically significant lesion(s) in below-knee popliteal or tibial vessels.

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