Temsirolimus adventitial delivery to improve Angiographic Outcomes below the knee
The TANGO Phase 2 trial was a prospective, multi-center, randomized dose escalation study to document the effects of adventitial delivery of temsirolimus (n=40) versus adventitial delivery of sham saline (n=20) after revascularization of lesions below the knee in symptomatic patients with severe claudication (Rutherford 3) or critical limb ischemia (CLI, Rutherford 4-5). Subjects were followed up for 12 months post-index procedure.
The principal analysis on the 53 per protocol (PP) patients in the TANGO trial revealed superior primary efficacy of the treatment arm, with absolute reduction in the absolute rate of clinically relevant target lesion failure reduced by 27.1% at 6 months. Subgroup analysis of all TASC B-D lesions (N=36) revealed absolute rate of clinically relevant target lesion failure reduced by 39.2%. Freedom from 30-day major adverse limb event or peri-operative death was 100% in all groups.