European Enrollment Begins for TOBA II BTK Trial of Intact Vascular's Tack Endovascular System
July 18, 2017—Intact Vascular, Inc. announced that its Tack Optimized Balloon Angioplasty II Below-the-Knee (TOBA II BTK) clinical trial has commenced enrollment in Europe, with the first patient treated by Professor Marianne Brodmann, MD, and Peter Rief, MD, at Medical University of Graz, Austria. The study will be conducted at up to 50 global sites and will enroll 232 patients. In February, the company announced the enrollment of the study's first patient in Yuma, Arizona.
According to the company, TOBA II BTK is a prospective, multicenter, single-arm study designed to investigate the safety and efficacy of Intact Vascular's Tack endovascular system in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischemia (CLI). The device repairs dissections in the artery wall that frequently occur as a complication of balloon angioplasty. Eligible patients will have diseased popliteal or tibial arteries treated with balloon angioplasty and have a dissection in the artery wall immediately following angioplasty.
In the company's announcement, Prof. Brodmann commented, “We are pleased to be the first center in Europe to commence enrollment in TOBA II BTK. I believe the Tack endovascular system is a very promising technology designed to optimize dissection repair while leaving a minimal metal footprint behind postimplantation.”
Dr. Rief added, "The spiral dissection we treated in this first patient was ideally suited for the Tack endovascular system since it is the only device uniquely designed to treat below-the-knee dissections following angioplasty.”
Andrej Schmidt, MD, is the European Principal Investigator for the TOBA II BTK clinical trial. He stated in the press release, "CLI is a serious disease that all too often leads to amputation. It is vital that we develop new technologies to restore and maintain blood flow to the lower leg and foot. I am pleased that we have commenced enrolling patients in European centers. The Tack endovascular system represents a major step forward in the endovascular treatment of CLI.”
The Tack device has received CE Mark approval in Europe but is not available for sale or commercial use in the United States, where it is limited by federal law to investigational use, advised the company. In January, 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.
Intact Vascular is sponsoring three clinical trials to evaluate its Tack endovascular system. TOBA II is investigating the combination of the Tack device with both plain and drug-coated balloon angioplasty in the arteries above the knee. TOBA II BTK is investigating the combination of the Tack device with plain balloon angioplasty in the arteries below the knee. TOBA III is currently underway in Europe and is investigating the combination of the Tack endovascular system with drug-coated balloon angioplasty.