PRECISE (Percutaneous Robotic-Enhanced Coronary Intervention Study), a trial assessing PCI procedures using the CorPath 200 system (Corindus Vascular Robotics), has been launched in New York City and Boston.
The trial is a prospective, single-arm, multi-center study, which will initially seek to enroll 154 patients. Investigators will evaluate the safety and effectiveness of the CorPath 200 system in delivering and manipulating coronary guidewires and stent/balloon systems in PCI procedures.
The trial is led by the co-principal investigators Giora Weisz, MD, co-director of clinical services at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of medicine at Columbia University College of Physicians and Surgeons, New York City, and Joseph P. Carrozza, MD, chief of cardiovascular medicine at St. Elizabeth’s Medical Center in Boston.
“For the very first time in my career, I was able to perform a PCI procedure without wearing a lead apron,” said Jeffrey W. Moses, MD, investigator of the CorPath PRECISE trial, director of interventional cardiology at NewYork-Presbyterian Hospital, director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center.
In addition to sites in New York City and Boston, the PRECISE trial will be conducted at medical centers across the U.S., including Virginia Commonwealth University Medical Center in Richmond, Va., St. Joseph’s Hospital Health Center in Syracuse, N.Y. , and Swedish Medical Center in Seattle.
The results of this study will be the basis for a pre-market clearance 510(k) application to the FDA, according to the Natick, Mass.-based company. The CorPath 200 system is an investigational device and limited by federal law to investigational use only.