Medtronic has commenced an IN.PACT BTK clinical study of IN.PACT 0.014 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter to treat patients with below-the-knee (BTK) peripheral arterial disease (PAD).
The study will evaluate the effectiveness of using a drug-coated balloon (DCB) in PAD treatment. IN.PACT 0.014 paclitaxel-coated PTA balloon catheter is an investigational device equipped with the firm's IN.PACT Admiral drug coating technology.
The prospective, randomised, multi-centre study will assess the catheter in up to 60 patients at four sites in Europe. The first patient was enrolled at Maria Cecilia Hospital in Cotignola, Italy.
Results from a preclinical study showed use of IN.PACT Admiral DCB in the superficial femoral arteries did not delay wound healing, despite measureable concentrations of paclitaxel in the adjacent cutaneous tissue.
Medtronic Peripheral's business vice-president and general manager Mark Pacyna said: "PAD below-the-knee is complex. With these prior analyses, we have developed an unmatched knowledge around the treatment of below-the-knee disease and critical limb ischemia (CLI).
"Together with our clinical investigators, we look forward to launching the IN.PACT BTK study to evaluate the effect of the IN.PACT 0.014 in patients with below-the-knee PAD."
The primary endpoint of the studies was late lumen loss at nine months, in patients who were treated with the IN.PACT 0.014 DCB, when compared to standard PTA.
A wound care protocol is also included in the study to provide additional safety controls and ensure both routine and standard monitoring of patients by qualified professionals.