On 5 October, Medtronic announced that patient enrolment in IN.PACT DEEP, a landmark study of its In.Pact Amphirion drug-eluting balloon, has been completed, with initial results expected in 2013.
The largest randomised controlled trial of its kind is designed to assess the safety and efficacy of the In.Pact Amphirion drug-eluting balloon as a treatment for below-the-knee critical limb ischaemia.
According to published data, 40% of critical limb ischaemia patients undergo amputation within 12 months of an episode, and their annual mortality rate is more than 20%.1-2
IN.PACT DEEP enrolled 357 patients across 13 sites, randomising them 2:1 to treatment with either the drug-eluting balloon (study arm) or conventional balloon angioplasty (control arm). Primary endpoints include 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. Other important endpoints, including wound healing and limb salvage rates, will also be examined and reported.
The principal investigators of IN.PACT DEEP are professors Iris Baumgartner of Bern University Hospital in Switzerland, Dierk Scheinert of the Heart Center in Leipzig, Germany and Thomas Zeller of the Heart Center in Bad Krozingen, Germany.
“As the largest below-the-knee critical limb ischaemia randomised trial, and the first and only drug-eluting balloon multicentre randomised trial of any kind, IN.PACT DEEP has the potential to shift the treatment paradigm for this challenging patient population,” said Baumgartner. “We look forward to sharing the initial safety, clinical and angiographic findings with the interventional community in 2013.”
Medtronic’s In.Pact drug-eluting balloons feature a proprietary coating called FreePac that is a formulation of paclitaxel and urea, an excipient that facilitates absorption of the drug into the vessel wall. They received the CE mark in 2008 and 2009 and are available in many countries around the world. They are not commercially available in the United States.
Ultimately, the global IN.PACT clinical programme will include 29 studies involving more than 4,600 patients and 230 sites worldwide. Through these company-sponsored and physician-initiated studies, Medtronic IN.PACT drug-eluting balloons will be investigated thoroughly for the treatment of arterial disease in coronary and peripheral vessel beds.
1 Dormandy J, Heeck L, Vig S. The fate of patients with critical leg ischemia. Semin Vasc Surg. 1999;12(2):142–147.
2.Dormandy J, Mahir M, Ascady G, et al. Fate of the patient with chronic leg ischaemia: A review article. J Cardiovasc Surg. 1989;30(1):50–57.