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Trial for DCB for below-the-knee PAD commences
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Medtronic announced the launch of a study for its drug-coated balloon in patients with below-the-knee peripheral artery disease.
The study will evaluate the effectiveness of the paclitaxel-coated DCB (IN.PACT 0.014) to treat below-the-knee lesions and critical limb ischemia compared with percutaneous transluminal angioplasty, according to a press release issued by the company.
The device uses Medtronic’s IN.PACT Admiral drug coating technology, according to the release.
"The first patient enrollment in the IN.PACT BTK study marks a landmark milestone in identifying a treatment option for below-the-knee PAD," Antonio Micari, MD, of Maria Cecilia Hospital in Cotignola, Italy, said in a press release. "Given the chronic nature and co-morbidities of this disease, there is a critical need for treatment options that are safe and durable. I look forward to continuing patient enrollment to evaluate the use of this DCB in treating this challenging disease state."
For the prospective, randomized trial, researchers will enroll approximately 60 patients at four sites in Europe. The primary endpoint is late lumen loss at 9 months. All patients will be routinely monitored by wound care professionals during the study, according to the release.
The device is not yet approved for use below the knee in the United States.
Disclosure: Micari reports consulting for Boston Scientific, Medtronic and Terumo.