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Clinical Trials

Topic   Cardiology
Title   GraftMaster RX Coronary Stent Graft System (JOSTENT)
Summary   The GraftMaster RX Coronary Stent Graft System is a special type of stent, (a device placed inside a heart artery) that is only used in an emergency situation when leakage or a perforation (hole) occurs in the artery.
Description   Percutaneous Coronary Intervention, (PCI) is a medical intervention for blocked coronary arteries or for patients who are suffering a heart attack. A small mesh tube, called a stent is placed to help increase the size of the narrowed or blocked arteries and to improve blood and oxygen flow to the heart. Very rarely, leakage or perforation of a coronary artery (heart vessel) may occur as a complication of PCI. The GraftMaster RX graft is used in these situations. It is classified as a Humanitarian Use Device (HUD), by the Food and Drug Administration (FDA) and is approved for use, even though its use is not technically research. HUD is a special FDA category for devices that are used to help patients with rare conditions, those that happen to less than 4,000 people in the US each year. Exactly how effective it is or what the long term effects are is not fully known. The GraftMaster RX is not used routinely. It is used only in an emergency, for a very rare, life-threatening complication of PCI.
IRB Number   15318
Inclusion/Notes   All patients who receive this rarely placed graft, in an emergency situation, are enrolled in this project.
Principal Name   Kevin Marzo, MD
Contact Name   Wendy Drewes, BSN, RN, CCRC, Dipti Patel, MSN, MPH
Email   wdrewes@nyuwinthrop.org, dpatel@nyuwinthrop.org
Phone   516-663-2929
Alternate Phone   516-663-8692