A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects with In-Stent Restenosis (ISR)
||Boston Scientific Corporation
||Male and Female Patients
|U.S. Govt. ID:
||Kate Dalton: 347-514-3366 / firstname.lastname@example.org
This is a prospective, multi-center, 2:1 randomized (AGENT to POBA), controlled, single-blind, superiority trial. The study is being done to look at the safety and effectiveness of the AgentTM drug-coated balloon compared to standard (non-drug coated) balloons also known as balloon angioplasty for the treatment of your re-narrowed blood vessel. In a balloon angioplasty, a specially designed thin wire called a catheter with a tiny balloon is carefully guided through the artery to the blockage. It is then inflated to widen the opening and increase blood flow to the heart. A stent is often placed during the procedure, to keep the artery open after the balloon is deflated and removed. The AGENT Study will be conducted at up to 40 sites in the United States with planned enrollment of 450 subjects; 300 subjects to receive treatment with the AGENT DCB investigational test device and 150 subjects to receive treatment with commercially available control device.
Jeffrey Moses, MD
|Have you been diagnosed with Coronary Artery Disease with planned stent placement?
|Have you been diagnosed with an in-stent restenosis (ISR), that is when an artery with a stent gets blocked or re-narrowed ?