AngioScore Begins FIH Study of Drug-Coated AngioSculpt Scoring Balloon Catheter

December 14, 2011—AngioScore, Inc. (Fremont, CA) announced the commencement of enrollment in the Drug-Coated AngioSculpt Scoring Balloon Catheter First-in-Human (FIH) study. The trial of the company's drug-coated scoring balloon will enroll 60 patients with coronary in-stent restenosis (ISR) at three international sites: two in Germany and one in Brazil. Prof. Bruno Scheller, MD, will lead the study.

“The development of a drug-coated AngioSculpt could represent a major advance in the percutaneous treatment of endovascular disease,” commented Prof. Scheller. “I am honored to lead this important study and to collaborate with such an internationally prominent interventional cardiologist as Prof. Alexandre Abizaid, MD, and his team at Dante Pazzanese Institute of Cardiology in São Paulo, Brazil.”



According to the company, the drug-coated AngioSculpt FIH study is designed as a randomized controlled trial and will compare the recently developed drug-coated AngioSculpt with the commercially available uncoated version in patients presenting with significant restenosis in a previously implanted coronary bare-metal stent. Patients will undergo follow-up coronary angiography at 6 months to compare the rate of recurrent restenosis and late lumen loss in both treatment arms. Additional study endpoints include the rate of major adverse cardiovascular events, clinically driven target lesion revascularization, and stent thrombosis for up to 2 years after the index procedure. All angiograms will be analyzed by an independent core laboratory at the Cardiovascular Research Foundation in New York, New York.


AngioScore stated that a drug-coated AngioSculpt device may allow a shortened course of dual-antiplatelet therapy and may allow for the treatment of patients presenting with challenging lesions that may not be suitable for stenting, including diffusely diseased and smaller-caliber vessels, restenosed stents, and certain peripheral vessels. The drug-coated AngioSculpt is currently investigational and not available for sale in the United States or Europe, advised the company.