QT Vascular said today that the FDA approved the company’s request to expand an on-going pivotal study of its Chocolate Touch drug-coated balloon to include the use of atherectomy for lesion preparation.
The U.S. regulatory agency also approved the addition of subgroup analysis related to the use of atherectomy.
The pivotal study of QT Vascular’s drug-coated balloon includes patients with disease in the superficial femoral and popliteal arteries in the legs.
Study participants are randomized 1:1 to receive either the Chocolate Touch device or C. R. Bard (NYSE:BCR) Lutonix drug-coated balloon, according to QT Vascular. The study’s endpoints include procedural successes, freedom from bail-out stenting, patency and target lesion revascularization.
“The inclusion of atherectomy in the study is a unique element that expands the potential use of Chocolate Touch, both in hospitals and OBL,” principal investigator Dr. Mehdi Shishehbor said in prepared remarks. “The study will provide an important data set that is consistent with real world practice, especially at OBL where more and more patients are getting treated.”
QT Vascular launched its U.S. pivotal trial for Chocolate Touch in July 2017.