Enrollment Begins in United States Pivotal Study of QT Vascular's Chocolate Touch DCB
August 3, 2017—QT Vascular Ltd. announced that it has commenced enrollment in its United States pivotal clinical study of the company's Chocolate Touch drug-coated balloon (DCB) for use in superficial femoral and popliteal arteries. The study is intended to support United States regulatory approval of the device. The Chocolate Touch device received European CE Mark approval in July 2015.
The Coprincipal Investigators of the study are Mehdi Shishehbor, MD, of the University Hospitals of Cleveland and Professor Thomas Zeller, MD, of the Heart Center in Bad Krozingen, Germany.
According to QT Vascular, the randomized study will compare two DCBs. The main objective of the study is to demonstrate the noninferior safety and effectiveness of the Chocolate Touch compared with the Lutonix DCB (Bard Peripheral Vascular, Inc.). The study is designed to further evaluate the superiority of Chocolate Touch over the Lutonix DCB.
Enrollment will include 510 randomized patients, with an interim analysis after 75% of the patients have completed 12-month follow-up. The company noted that this analysis can potentially support earlier submission of the results. The primary effectiveness endpoint is true DCB success, which is defined as a composite result requiring patients to achieve primary patency in the absence of bailout stenting.
The company advised that 12-month outcomes in the Chocolate Touch ENDURE trial showed an incidence of bailout stenting of 1.4%, with a primary patency rate of 83.6% and Kaplan-Meier patency of 89.9%.
In QT Vascular's press release, Prof. Zeller commented, "I'm delighted to start enrollment in this important study. We believe that the unique properties of Chocolate, namely larger lumen with less dissections and bailout stenting, make this a differentiated DCB option. This head-to-head study against Lutonix DCB is set up to demonstrate this point."
Dr. Shishehbor added, "We are excited about the first patient enrollment in this worldwide study evaluating Chocolate, a second-generation DCB. This first-of-a-kind trial will help guide physicians as they choose the best DCB for their patients."