ENDURE Trial of QT Vascular's Chocolate Touch DCB Enrolls First European Patients

September 15, 2014—QT Vascular Ltd. announced that the first European patients in the ENDURE trial have been enrolled in Germany. ENDURE is evaluating the efficacy of Trireme Medical LLC’s Chocolate Touch peripheral drug-coated balloon (DCB) for percutaneous transluminal angioplasty (PTA).

California-based Trireme Medical is a wholly owned subsidiary of QT Vascular, which is headquartered in Singapore. In July 2014, QT Vascular announced that it has applied for European CE Mark approval for the Chocolate Touch.

ENDURE is a single-arm, core-lab–adjudicated, multicenter clinical trial conducted at top centers in Europe and New Zealand. Clinical assessment at 30 days, 3 months, 6 months, and 12 months will include amputation-free survival and Rutherford grade change, while core lab measurements will include late lumen loss, patency, and target lesion revascularization. Multiple patients have already been enrolled in this study with Andrew Holden, MD, at Auckland City Hospital in Auckland, New Zealand.

According to the company, the peripheral Chocolate Touch DCB combines the acute benefits of the Chocolate PTA balloon catheter with the potential long-term benefits of a paclitaxel-based coating.  

The first European patient was treated at the Department of Angiology at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany. A 6- X 40-mm Chocolate Touch DCB was used to successfully dilate a subtotal occlusion of the superficial femoral artery. Professor Thomas Zeller, MD, head of the Department of Angiology, commented in the company’s press release, “Chocolate’s mechanism of action minimizes vessel trauma and therefore reduces the chances of a dissection. Now coupled with a drug, it could provide an option for patients to leave the hospital without a permanent implant.”

Used for the treatment of patients with peripheral arterial disease, the Chocolate platform was designed to provide predictable, uniform, less-traumatic dilatation. The company noted that the platform does not require predilatation and has a larger contact surface for drug transfer. Additionally, the Chocolate platform demonstrated a very low rate of dissections and bailout stenting in data from the Chocolate BAR Registry that was presented in January by Tony Das, MD, at LINC 2014: the Leipzig Interventional Course.

The Chocolate balloon catheter was cleared for use in the peripheral vasculature in Europe in January 2011 and in the United States in December 2011.

On June 5, the company received US Food and Drug Administration 510(K) clearance to market the coronary Chocolate PTA balloon catheter in the United States for the treatment of blocked coronary arteries. In February 2014, Cordis Corporation announced an agreement with TriReme Medical for exclusive distribution rights for the Chocolate PTA balloon catheter.

In a Cordis-sponsored Featured Technology article in the May 2014 issue of Endovascular Today, Charisse Ward, MD, and Carlos Mena-Hurtado, MD, discussed the use of the Chocolate PTA balloon catheter for reducing trauma and improving outcomes in complex lower extremity interventions (2014;5:24–28).

QT Vascular advised that other products in the development pipeline include the Silk PTA balloon catheter, a version of Chocolate PTA that is made for intervention in longer lesions. The Silk PTA is currently at the design feasibility stage, with CE Mark submission targeted for the first quarter of 2015.