Enrollment Completed for First-in-Human Study of AngioScore's AngioSculpt

June 19, 2013—AngioScore, Inc. (Fremont, CA) announced the completion of enrollment in the PATENT-C first-in-human (FIH) study of the company's drug-coated AngioSculpt scoring balloon catheter. The company anticipates that preliminary data from this study will be available for presentation at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference on October 28–November 1 in San Francisco, California.

According to the company, this FIH trial enrolled 61 patients with coronary in-stent restenosis at five international sites, four in Germany and one in Brazil. The study is led by Bruno Scheller, MD, Professor of Interventional Cardiology at Saarland University Hospital, Homburg, Germany.

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

The company advised that the drug-coated AngioSculpt FIH study was designed as a randomized controlled trial comparing the recently developed drug-coated AngioSculpt with the commercially available uncoated version of the AngioSculpt 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 following the index procedure. All angiograms will be analyzed by an independent core laboratory at the Cardiovascular Research Foundation in New York, New York.

The drug-coated AngioSculpt scoring balloon catheter is an investigational device, limited by applicable law to investigational use and not available for sale, noted the company.