Intact Vascular’s TOBA II BTK Trial Begins Enrollment
February 22, 2017—Intact Vascular, Inc. announced that enrollment has begun for the Tack Optimized Balloon Angioplasty II Below-the-Knee (TOBA II BTK) clinical trial. TOBA II BTK is a prospective, multicenter, single-arm study designed to investigate the safety and efficacy of the Tack endovascular system in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischemia (CLI).
According to the company, the TOBA II BTK study will be conducted at up to 50 global sites and will enroll a total of 232 patients. Patients will be eligible if they have diseased popliteal or tibial arteries treated with balloon angioplasty and have a dissection in the artery wall immediately after angioplasty. Staged approval of the study was announced by the US Food and Drug Administration in October 2016.
The first patient was treated by Joseph Cardenas, MD, at Yuma Regional Hospital and the Heart, Lung, and Vascular Center in Yuma, Arizona. In the company's press release, Dr. Cardenas commented, “One of our key goals when we perform angioplasty in patients with CLI, is to restore blood flow to the foot, and keeping the treated arteries open over time is a major challenge. The Tack system is uniquely designed to repair dissections following angioplasty while minimizing arterial inflammation and leaving little foreign material behind. I believe this represents an ideal combination for maintaining long-term arterial patency.”
Dr. Cardenas added, “The TOBA II BTK trial will provide us with valuable information about this very promising technology designed to optimize angioplasty results in CLI. We are thrilled to be the first center to begin enrollment in this important study.”
The Tack endovascular system is designed to repair dissections in the artery wall that frequently occur as a complication of balloon 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. In the United States, the Tack device is limited to investigational use only, in both the TOBA II trial for above-the-knee treatment and the TOBA II BTK study, advised Intact Vascular.
In January 2017, the company announced European CE Mark approval for an expanded indication for the Tack endovascular system for the repair of below-the-knee arterial dissections after angioplasty.