Intact Vascular's TOBA II Trial Completes Enrollment in Europe and the United States
March 23, 2017—Intact Vascular, Inc. announced that the company's Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial has completed enrollment with 210 patients at 33 sites in the United States and Europe. The TOBA II trial is a prospective, multicenter, two-arm, nonrandomized study designed to investigate the safety and efficacy of Intact Vascular's Tack endovascular system in combination with standard or drug-coated balloon (DCB) angioplasty in the arteries above the knee. Target vessels include the superficial femoral artery and the proximal segment of the popliteal artery.
According to the company, the Tack system is designed to repair dissections in artery walls that frequently occur as a complication of standard or DCB angioplasty. The system allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options.
Intact Vascular noted that the design of TOBA II permits the use of the Tack system following either standard, uncoated angioplasty, or angioplasty using the Lutonix DCB (Bard Peripheral Vascular, Inc.). Patients are enrolled in either group based on the treating physician’s clinical judgment. The primary effectiveness endpoint for TOBA II is duplex-derived patency at 12 months after treatment.
William Gray, MD, who serves as the National Principal Investigator for the TOBA II study, commented in the company's announcement, “TOBA II is a unique clinical study which will give us important insights into a new approach to dissection repair that holds great promise for advancing the endovascular treatment of peripheral artery disease. I extend my sincere appreciation and congratulations to all of the investigators and their teams for making the timely achievement of this milestone possible.” Dr. Gray is System Chief of the Main Line Health Cardiovascular Disease Division in Wynnewood, Pennsylvania.
In February, Intact Vascular announced the start of enrollment in the company-sponsored TOBA II BTK study, which is investigating the combination of the Tack endovascular system with plain balloon angioplasty in the arteries below the knee.
In June 2016, the company announced the commencement of enrollment in TOBA III, which is currently underway in Europe and is investigating the combination of the Tack endovascular system with the In.Pact Admiral DCB (Medtronic).