Medical device firm Intact Vascular has closed enrollment in the tack optimised balloon angioplasty II (TOBA II) clinical trial of its Tack Endovascular system to treat patients with peripheral arterial disease (PAD).
The Tack Endovascular system technology is being developed to repair dissections/tears that occur in artery walls during standard or drug coated balloon (DCB) angioplasty.
The prospective, multi-centre, two-arm, non-randomised TOBA II trial has enrolled a total of 210 patients at 33 sites in the US and Europe.
The trial evaluated the the safety and efficacy of the Tack Endovascular system in combination with standard or DCB angioplasty using the BARD Lutonix in the arteries above the knee.
The superficial femoral artery (SFA) and the proximal segment of the popliteal artery have been targeted during the trial.
Intact Vascular co-founder and chief medical officer Dr Peter Schneider said: “The Tack Endovascular system was conceived as a minimal metal approach to dissection repair, and that idea has become even more important with the advent of drug coated balloon angioplasty."
The trial's primary effectiveness endpoint is Duplex derived patency at 12 months after treatment.
The Tack system allows repair while leaving a minimal amount of foreign material in the artery, it reduces mechanical stress on the artery and preserves future treatment options.
The system is being investigated further in TOBA II BTK trial which includes combination of the system with plain balloon angioplasty to target the arteries below the knee, and TOBA III trial which involves its combination with Medtronic's IN.PACT Admiral DCB in Europe.