Post-Market Clinical Study Protocol DCR4 Contrast Clinical Evidence Study
Study of Dynamic Coronary Roadmap Software During Percutaneous Coronary Intervention (DCR4Contrast Clinical Evidence Study)
Sponsor: Philips
Enrolling: Male and Female Patients
IRB Number: AAAS5250
U.S. Govt. ID: NCT04085614
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: This study is trying to determine if using a Dynamic Coronary Roadmap (which is a software used along with an x-ray imaging system) reduces the total iodine contrast volume per Percutaneous Coronary Intervention (PCI) procedure compared to procedures performed without Dynamic Coronary Roadmap. This X-ray system provides imaging support while directing the stent device via the artery in your groin or arm to the coronary artery. During the procedure, iodine contrast fluid is repeatedly injected in your coronary arteries to visualize the coronary arteries on X-ray. This lasts only for a short moment because the contrast is washed away by the blood flow. The Dynamic Coronary Roadmap helps the doctor in directing the stent device to the narrowed vessel by continuously visualizing the coronary arteries on the screen without the need for contrast injection. It does so by processing X-ray images with iodine contrast once and then continuously reusing and showing that visualization of the coronary arteries on top of live X-ray imaging without iodine contrast injection. Dynamic Coronary Roadmap, therefore, has the potential to reduce contrast fluid during the PCI procedure.
Investigator
Ajay Kirtane, MD, SM
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366