CorPath PRECISION Registry
The PRECISION Study, a multicenter post-market registry for the evaluation of the CorPath System effectiveness in percutaneous coronary interventions, aims to collect data on the routine use of the CorPath. Corindus is interested in learning about the patterns of the CorPath's use, safety, and effectiveness from an all-comers' perspective. The PRECISION Registry is being conducted under the leadership of Principal Investigator, Dr. Giora Weisz, Director of Clinical Cardiovascular Research at the Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical Center.
If you are interested in participating in the CorPath PRECISION Registry, please click below:
Learn more by visiting clinicaltrials.gov
CorPath PRECISE Trial
The CorPath Percutaneous Robotically- Enhanced Coronary Intervention Study (PRECISE) aimed to expand and verify safety and technical efficacy of CorPath System use in the robotic manipulation of coronary guidewires and stent/balloon systems. The PRECISE trial was conducted under Principal Investigators, Dr. Giora Weisz, Director of Clinical Cardiovascular Research at the Center for Interventional Vascular Therapy at NewYork Presbyterian Hospital/Columbia University Medical Center and Dr. Joseph Carrozza, Chief of Cardiovascular Medicine at St. Elizabeth's Medical Center in Boston. Criteria for participation included patients 18-99 years old, male or female, with a single de novo stenosis >50%, occlusions under 25 mm long in vessels 2.5 to 4 mm in diameter, by visual estimate.
The CorPath PRECISE Study was sponsored by Corindus Vascular Robotics under Investigational Device Exemption (IDE) approval from the FDA to obtain 510(k) clearance. The study was a prospective, multicenter, open-label, non-randomized study, enrolling 164 patients at nine clinical trial sites. Physicians participating in the study did not receive any direct financial compensation. Results of the CorPath PRECISE trial were published in the April 2013 issue of the Journal of the American College of Cardiology. The study reported a successful PCI completion with use of the CorPath System in 162 of the total 164 cases. In the two outstanding cases, the interventionalist left the CorPath cockpit to complete the procedure manually, resulting in an incomplete use of the CorPath System, but clinically successful procedures.
There were no reports of device-related complications and an overall clinical success rate of 97.6%. The average radiation exposure to the cardiovascular interventionalist decreased by 95.2%, in contrast to levels reported during standard interventions.
| ||PRECISE Study |
|Age ||64.1 ± 10.0 |
|Number of Stents ||1.1 ± 0.34 |
|Lesion Length (mm) ||13.4 ± 4.0 |
|Fluoroscopy time (min) ||10.6 ± 6.2 |
|Contrast Volume (ml) ||144.2 ± 70 |
|Metric ||Radiation Exposure (μGy) |
|Primary Operator ||Procedure table ||Reduction (%) |
|Median ||0.98 ||20.6 ||95.2%* |
|* Powered secondary endpoint of at least 50% reduction in primary operator radiation exposure was achived with p<0.0001 |
First in Man Trial
In April 2011, the First in Man Trial (FIM) for the CorPath Robotic-assisted PCI System was published in the Journal of the American College of Cardiologists. This clinical study enrolled eight patients with coronary artery disease who required a PCI procedure at the Corbic Research Institute in Envigado, Colombia. All patients were treated for a single de novo coronary lesion up to 25mm in length located in a vessel 2.5-4.0mm in diameter. The procedure was successfully completed in all 8 patients utilizing the CorPath System to advance coronary guidewires and perform the intervention; there were no reported device or procedure-related complications/major adverse cardiac events. Operator radiation exposure was 97% lower with the use of the CorPath System in comparison with levels found at the standard table position.