A universal drug delivery catheter for the treatment of infrapopliteal arterial disease: Results from the multi‐center first‐in‐human study

2018 
Objective The objective of this study was to assess the feasibility, safety and initial efficacy of paclitaxel administration using a novel drug delivery catheter for the prevention of restenosis in infrapopliteal de novo and restenotic lesions. Background Restenosis continues to be a great challenge after percutaneous revascularization procedures for peripheral arterial disease, particularly for below-the-knee applications. Methods A prospective, multicenter first-in-human registry of a novel delivery catheter delivering liquid paclitaxel was conducted in 10 patients. The primary efficacy endpoint at 6 months was freedom from clinically driven target lesion revascularization (CD-TLR) and the primary safety endpoint at 1, 3, and 6 months were thrombosis, major amputation in the target limb and target limb related death. Results All patients tolerated the procedure well with no reports of adverse procedural events. Twelve (n = 12) lesions in ten patients were treated with a mean lesion length of 83.3 ± 49.2 mm, with the lesion length range of 30mm to 182 mm. At 6-month follow-up, the rate of CD-TLR was 30% (3 of 10 patients). Zero patients (0 out of 10) demonstrated thrombosis, major amputation in the target limb and target limb related death at the 1, 3, and 6 month follow-up intervals. Conclusions This first in-human experience obtained in a multicenter study of real-world de novo and restenotic lesions demonstrates a favorable safety and efficacy profile at 6 months. Randomized comparison to current drug coated balloons should be performed to further validate this approach and positive experience.
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