Coronary Stent Graft Using Humanitarian Device Exemption (HDE)

Condition/Intervention: Coronary artery disease

Eligibility

Key Inclusion Criteria

  • Coronary artery perforation

Key Exclusion Criteria

  • Pregnant women
  • Children

Full Study Name

Jostent: Graftmaster RX Coronary Stent Graft for Commercial Use in Selected Patients Through a Humanitarian Device Exemption (HDE) (IRB no. 4195)

Summary

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.

Status

Active

Date Last Updated

06/15


Principal Investigator

Raj Makkar, MD

Co-Investigators

Suhail Dohad, MD

Contact