The FDA has granted approval to include the use of atherectomy for lesion preparation in its ongoing US pivotal study of the Chocolate Touch drug-coated balloon (DCB; QT Vascular) and the addition of subgroup analysis related to the use of atherectomy.
The Chocolate Touch device is the drug-coated version of the company’s Chocolate percutaneous transluminal angioplasty balloon, which was acquired by Medtronic in January 2018 and is commercially available in the USA.
The prospective, randomised Chocolate Touch pivotal study is being conducted in up to 50 centres in the USA, and selected centres in Europe and New Zealand. The study’s co-principal investigators are Mehdi Shishehbor (Cleveland, USA) and Thomas Zeller (Bad Krozingen, Germany).
In the company’s press release, Shishehbor comments: “The inclusion of atherectomy in the study is a unique element that expands the potential use of Chocolate Touch, both in hospitals and out-patient–based labs. The study will provide an important data set that is consistent with real-world practice, especially at [out-patient–based labs] where more and more patients are getting treated.”
The study is evaluating patients with disease in the superficial femoral and popliteal arteries in the legs. Patients are randomised 1:1 to the Lutonix DCB (BD). The study evaluates acute endpoints such as procedural successes and freedom from bail-out stenting, and long-term endpoints such as patency and target lesion revascularization among others.
The Chocolate Touch DCB is not commercially available in the USA, and can only be used in the investigational device exemption clinical study. The device received CE mark in August 2015 and is available in the European Union and other countries.