Intact Vascular has announced that its Tack Optimised Balloon Angioplasty III (TOBA III) clinical trial has commenced enrolment, with the first patient treated by Klaus Brechtel at the Franziskus-Hospital in Berlin, Germany.
The TOBA III study is a prospective, multicentre, single-arm study designed to investigate the safety and efficacy of the Tack endovascular system in combination with the Medtronic Admiral drug-coated angioplasty balloon in the treatment of peripheral arterial disease in the superficial femoral and popliteal arteries. The Tack endovascular system is a new technology designed to repair dissections in the artery wall. The system is intended to allow 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.
Brechtel states, “One of our key goals when using drug coated balloons to perform peripheral angioplasty is to minimise inflammation of the treated artery and leave little foreign material behind. The Tack system is designed to allow us to repair arterial damage after angioplasty while minimising vessel irritation and leaving far less metal behind than we would with the traditional stenting approach.”
The TOBA III study is to be conducted at multiple sites across Europe and aims to enrol 200 patients in total, including a subgroup of patients with long arterial lesions. Eligible patients will have peripheral arterial disease treated with balloon angioplasty using the Medtronic IN.PACT Admiral drug-coated balloon and have a dissection in the artery wall immediately following angioplasty.
Intact Vascular is also sponsoring the TOBA II study, which is investigating the combination of the Tack endovascular system with uncoated angioplasty balloons and the Bard Lutonix drug-coated balloon in patients with superficial femoral and popliteal artery disease. According to a company release, future plans include conducting the TOBA II below-the-knee clinical trial to assess the performance of the Tack endovascular system following balloon angioplasty in patients with arterial disease below the knee.