The First-in-Human Evaluation of the Drug-Coated Chocolate Balloon for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease assessed a drug-coated balloon (Chocolate Touch, QT Vascular/TriReme Medical) for angioplasty in patients with symptomatic peripheral artery disease.

Design: Open-label, single-arm

Patients: 67

Centers: 4

Countries: Germany, New Zealand

Results: Technical success, defined as delivery without geographic miss, was 100%. There were no cases of flow-limiting dissection. In one patient, bailout stenting was required. At 6 months, the rate of clinically driven target lesion revascularization was 1.7%, there was one death, there were no amputations and there was a mean improvement of 2.5 Rutherford classes. The 6-month patency rate was 90% per protocol and 87% overall. Mean late lumen loss was 0.16 mm.

Original Publication:
Shishehbor MH, et al. J Am Coll Cardiol. 2016;doi:10.1016/j.jacc.2016.09.806.

Healio/Cardiology News Coverage:
ENDURE: Next-generation DCB shows promise in patients with PAD