Coronary Stent Graft Using Humanitarian Device Exemption (HDE)
Condition/Intervention: Coronary artery disease
Key Inclusion Criteria
- Coronary artery perforation
Key Exclusion Criteria
- Pregnant women
Full Study Name
Jostent: Graftmaster RX Coronary Stent Graft for Commercial Use in Selected Patients Through a Humanitarian Device Exemption (HDE) (IRB no. 4195)
The purpose of this study is to evaluate the success and safety of the JOSTENT Graftmaster RX Coronary Stent Graft as a life-saving treatment in patients who have a coronary artery perforation. A perforation (hole) in the coronary artery can be life-threatening, as blood that feeds the heart muscle escapes through this hole. The JOSTENT® is a device that can close such a perforation.
The JOSTENT Graftmaster RX Coronary Stent Graft is a Humanitarian Use Device (HUD), a designation for devices that will be used to treat fewer than 4,000 people a year.
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