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JOSTENT GraftMaster
Summary
The clinical study is in place so that the JOSTENT GraftMaster Coronary Stent Graft system is available to those patients who may emergently need it. The FDA has approved the JOSTENT for commercial use in selected patients under a Humanitarian Device Exemption (HDE) for use in the treatment of free perforations in native vessels or saphenous vein bypass grafts greater than or equal to 2.75 mm in diameter.
Description
Winthrop-University Hospital - Division of Cardiology is participating in this clinical study so that the JOSTENT is available to those patients who may emergently need it. A JOSTENT is a special type of stent that can be placed in a patient's coronary artery should a leakage or perforation occur. Such a leakage is rare, but may occur as a complication of the coronary intervention. The JOSTENT is a humanitarian use device (HUD) and is not routinely used. It is used only in a potentially serious and life-threatening situation.
Inclusion/exclusion
The FDA has approved the JOSTENT for commercial use in selected patients under a Humanitarian Device Exemption (HDE) for use in the treatment of free perforations in native vessels or saphenous vein bypass grafts greater than or equal to 2.75 mm in diameter.
Principal Investigator
Kevin Marzo, MD
Department
Division of Cardiology
Email
kmarzo@winthrop.org
Other Contact
For more information please call Research Coordinator at 516-663-8692.
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