Thomas Zeller (Bad Krozingen, Germany) delves into data and design of the TOBA II (Tack Optimized Balloon Angioplasty II) trial with principal investigator William Gray (Philadelphia, USA) for Vascular News. Gray, who presented the one-year findings of TOBA II in the late-breaking scientific session at VIVA 2018 (5–8 November, Las Vegas, USA), also highlights the design of the Tack Endovascular System® (Intact Vascular) and says this data positions the system nicely as an augmentation to any balloon procedure, whether it is plain balloon angioplasty or angioplasty using a drug-coated balloon.
The TOBA II pivotal trial is the first peripheral vascular study to enroll patients with 100% dissected vessels to investigate the Tack Endovascular System for the repair of post-angioplasty dissections in femoropopliteal arteries. All patients enrolled (n=213) suffered from peripheral arterial disease (PAD), underwent balloon angioplasty with either plain or drug-coated balloons (Lutonix®, BD), and consequently experienced at least one dissection, with 69.4% being classified as severe. Results presented from this study demonstrated 92.1% complete dissection resolution within a clinically challenging patient population, along with 79.3% Kaplan-Meier (K-M) vessel patency and 86.5% K-M freedom from clinically-driven reintervention at 12-months. Additionally, the TOBA II study validated the Tack implants as stable and durable, with zero implant fractures, 99.9% freedom from migration, and a 0.5% bailout stent rate.
This video was sponsored by Intact Vascular.