Medical device firm Intact Vascular has closed enrolment in the tack optimised balloon angioplasty II BTK (TOBA II BTK) clinical trial of its Tack Endovascular system to treat patients with critical limb ischemia (CLI).
Tack Endovascular System is an implantable, repair device intended for the treatment of peripheral arterial dissections after balloon angioplasty in above or below-the-knee procedures.
The single arm, prospective TOBA II BTK trial recruited 233 CLI patients, who had standard balloon angioplasty and experienced at least one dissection requiring repair, at 41 sites in the US and Europe.
TOBA II BTK has been designed to investigate the safety and efficacy of the device in repairing post-angioplasty dissections in the mid/distal popliteal, tibial and peroneal arteries.
It involves a combination of the Tack system and plain balloon angioplasty in the arteries below the knee.
Intact Vascular co-founder and chief medical officer Peter Schneider said: “As the first dissection repair device purpose-built for use in these small vessels, we are excited to provide a solution for patients suffering the painful and debilitating effects of critical limb ischemia and who currently do not have adequate treatment options available.
“The Tack implant is a novel adjunct therapy that should diminish the chance that these patients will require an amputation.”
The company initiated enrolment in the TOBA II BTK trial in February 2017. The study is part of Intact Vascular’s clinical programme for the Tack Endovascular System.
Currently, the TOBA II trial is evaluating the combination of the Tack Endovascular system with plain angioplasty balloons and the BARD Lutonix drug-coated balloon (DCB) in arteries above the knee.
A separate study, TOBA III, is exploring the combination of the Tack implant with Medtronic ’s IN.PACT Admiral DCB. This trial completed enrolment in Europe.