Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK)

, Patrick J. Geraghty, George L. Adams, Andrej Schmidt, Michael Lichtenberg, Christian Wissgott & Klaus Hertting
Purpose: To report the 12-month safety and efficacy outcomes of the investigational device exemption trial evaluating an implantable below-the-knee (BTK) dissection repair device. Materials and Methods: The prospective, multicenter, single-arm Tack-Optimized Balloon Angioplasty (TOBA) II BTK study (ClinicalTrials.gov identifier NCT02942966) evaluated the Tack Endovascular System in the BTK arteries vs objective performance goals derived from a systematic review of BTK angioplasty literature. Patients presenting with Rutherford category 3–5 ischemia were eligible and were enrolled during...
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