Medical devices developer Intact Vascular has begun enrolment in the tack optimised balloon angioplasty II below the knee (TOBA II BTK) trial of its Tack Endovascular system to treat patients with critical limb ischemia (CLI).
The Tack Endovascular system is a new technology developed to repair dissections/tears in the artery wall that might occur during balloon angioplasty.
The system enables physicians to leave a minimal amount of foreign material in the artery during the repair, which results in decreased mechanical stress on the artery and allows future treatment options.
The US Food and Drug Administration (FDA) approved prospective, multi-centre, single-arm TOBA II BTK trial is designed to evaluate a permanent vascular implant in arteries below the knee.
It will investigate the safety and efficacy of the Tack Endovascular system in combination with standard balloon angioplasty in the popliteal and tibial arteries.
The system is designed to optimise peripheral balloon angioplasty results in the treatment of peripheral arterial disease.
To be conducted at up to 50 global sites, the clinical trial will enroll 232 patients with diseased popliteal or tibial arteries treated with balloon angioplasty and have a dissection in the artery wall immediately after the procedure.
The firm is further evaluating the system in a TOBA II trail, in combination with both uncoated angioplasty balloons and the BARD Lutonix drug-coated balloon in patients with superficial femoral and popliteal artery disease.
A TOBA III study by the firm is assesing the combination of the Tack Endovascular system with the Medtronic IN.PACT Admiral drug-coated balloon in similar subjects.