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

"Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: George L. Adams is a consultant/advisory board member for Abbott Vascular, Bard, Boston Scientific, Cook Medical, W.L. Gore & Associates, Medtronic, and Cordis, a Cardinal Health Company. Ehrin J. Armstrong is a consultant/advisory board member for Abbott Vascular, Boston Scientific, Cardiovascular Systems, W.L. Gore & Associates, Intact Vascular, Janssen, Medtronic, and Philips Healthcare. Patrick J. Geraghty is a consultant/advisory board member for Bard Peripheral Vascular, Boston Scientific, and Ascension Ventures; he has an equity investment in Euphrates Vascular. Michael Lichtenberg is a consultant/advisory board member for Intact Vascular. Andrej Schmidt is a consultant/speaker for Abbott Vascular, Bard/BD, Cook Medical, Reflow Medical, Upstream Peripheral, and Cordis, a Cardinal Health Company. Christian Wissgott is a consultant/advisory board member for Intact Vascular."

"Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was funded by Intact Vascular, Inc."

"The 4-F Tack Endovascular System (Intact Vascular, Wayne, PA, USA) is specifically designed for infrapopliteal post-PTA dissection repair. Because the Tack-Optimized Balloon Angioplasty (TOBA) II BTK study was the first investigational device exemption (IDE) study to evaluate a BTK implant for this indication, there was no approved implant to be compared in a randomized controlled trial. Instead, a prospective, multicenter, single-arm trial of the Tack Endovascular System was designed to be consistent with the safety objective performance goal (OPG) established by the Society for Vascular Surgery Critical Limb Ischemia Working Group’s guidance published in 2009. Efficacy OPGs were derived from a systematic review of the BTK angioplasty literature. Details of the TOBA II BTK study design and the derivation of its OPGs have been described. The TOBA II BTK study protocol was approved by all relevant institutional review boards of the 41 sites () in the United States, Europe, and New Zealand. The trial was conducted in compliance with the Declaration of Helsinki, International Conference on Harmonization E6–Good Clinical Practice, and ISO 14155. Independent imaging core laboratories adjudicated all study angiograms (Yale Cardiovascular Research Group, New Haven, CT, USA) and duplex ultrasound scans (VasCore, Massachusetts General Hospital, Boston, MA, USA). Safety outcomes were adjudicated by an independent Clinical Events Committee (CEC), with patient safety and scientific integrity overseen by an independent Data Safety Monitoring Board. The trial was registered on the National Institutes of Health website (ClinicalTrials.gov identifier NCT02942966)."