William A. Gray, MD, system chief of the division of cardiovascular disease at Main Line Health and president of Lankenau Heart Institute, led the first peripheral vascular clinical study to enroll patients with 100% dissected vessels. He presented the one-year results of the study at the annual Vascular InterVentional Advances conference held in Las Vegas Nov. 5-8.
The Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial, on which Dr. Gray was the principal investigator, enrolled 213 patients at 33 U.S. and European sites. Researchers sought to determine how effectively the Tack Endovascular System (Intact Vascular, Inc.) was able to repair femoropopliteal arteries following standard balloon angioplasty. All patients in the study had peripheral artery disease, had undergone balloon angioplasty and had experienced at least one dissection, with close to 70 percent classified as severe.
The study found that 92 percent of dissections were successfully resolved with the use of the Tack Endovascular System. At 12 months, results included improved vessel patency (79% Kaplan-Meier), and freedom from clinically driven reintervention was 86% (Kaplan-Meier). The TOBA II study also demonstrated the Tack implants to be stable and durable, with zero implant fractures, 99.9% freedom from migration, and a 0.5% bailout stent rate. Compared to predicate data from prior balloon angioplasty, these results represented an improvement in one-year outcomes.
“The TOBA II study is unique in that it is the first large-scale pivotal evaluation in peripheral arterial vessels that are 100% dissected following initial angioplasty and treated with a precisely targeted implant,” said Dr. Gray, who also serves as a clinical professor of the Lankenau Institute for Medical Research, the research division of Main Line Health. “This study introduces a new therapeutic paradigm, demonstrating that we can repair dissected arteries, leaving minimal metal behind to preserve future treatment options for our patients, and producing excellent 12-month outcomes.”