IRB Study Number 25-746
Status Recruiting
Institute Heart and Vascular Institute
Description
The purpose of this clinical trial is to assess the safety and effectiveness of the AGENT Paclitaxel Coated Balloon Catheter (AGENT Drug-Coated Balloon, AGENT DCB) compared to standard of care percutaneous coronary intervention (PCI) treatment for de novo coronary lesions.
Inclusion Criteria
Subject must be at least 18 years of age.
Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.
Subject is eligible for percutaneous coronary intervention (PCI).
Exclusion Criteria
Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 12 months.
Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).
Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.
