Medtronic has completed enrolling patients in its IN.PACT DEEP trial, designed to demonstrate the safety and efficacy of Amphirion drug-eluting balloon in treating critical limb ischemia.
The CE-marked Amphirion drug-eluting balloon features a proprietary FreePac coating made of paclitaxel and urea, which facilitates absorption of the drug into the vessel wall.
The controlled, multicentre, randomised trial has enrolled 357 patients across 13 sites to evaluate the potential of Amphirion balloon in restoring blood flow to the lower extremities.
According to published data, within 12 months of an episode of critical limb ischemia, 40% patients undergo amputation and their annual mortality rate is more than 20%.
Patients are randomised in 2:1 ratio to either receive the drug-eluting balloon (study arm) or conventional balloon angioplasty (control arm).
Late lumen loss and clinically-driven target lesion revascularisation (TLR) at 12 months, as well as a composite of all-cause mortality, major amputation and clinically-driven TLR at six months are the primary endpoints for the trial.
Other important endpoints, including wound healing and limb salvage rates, will also be examined and reported, according to the company.
Bern University Hospital professor and study principal investigator Iris Baumgartner said: "As the largest below-the-knee critical limb ischemia randomized trial, and the first and only drug eluting balloon multicenter randomized trial of any kind, IN.PACT DEEP has the potential to shift the treatment paradigm for this challenging patient population."
The company is looking forward to share the initial safety, clinical and angiographic findings with the interventional community in 2013.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: courtesy of Bobak Ha'Eri.