QT Vascular has started enrolment in its US pivotal clinical study. The study will evaluate the company’s Chocolate Touch drug-coated balloon (DCB), for use in superficial femoral and popliteal arteries.
The study is intended to support US Food and Drug Administration approval of the device.
The co-principal investigators of the study are Mehdi Shishehbor of the University Hospitals of Cleveland, Cleveland, USA, and Thomas Zeller of the Heart Center in Bad Krozingen, Germany.
The clinical trial is a first of its kind, randomised study comparing two DCBs. The main objective of the study is to demonstrate non-inferior safety and effectiveness of the Chocolate Touch compared to Lutonix DCB catheter from Bard.
The study is designed to further evaluate superiority of Chocolate Touch over Lutonix DCB. Enrolment will include 510 randomised patients, with an interim analysis after 75% of the patients completed 12-month follow-up. This analysis can potentially support earlier submission of the results. The primary effectiveness endpoint is “true DCB success,” a composite result requiring patients to achieve primary patency in the absence of bailout stenting.
“I’m delighted to start enrolment in this important study,” says Zeller. “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.”
“We are excited about the first patient enrolment in this worldwide study evaluating Chocolate, a second-generation DCB,” says Shishehbor. “This first of a kind trial will help guide physicians as they choose the best DCB for their patients.”
The company’s 12-month outcomes in Chocolate Touch ENDURE study showed an incidence of bailout stenting of just 1.4%. The primary patency rate was 83.6% and the Kaplan Meier patency 89.9%.