Jostent: Graftmaster RX Coronary Stent Graft for Commercial Use in Selected Patients Through a Humanitarian Device Exemption (HDE)

Condition/Intervention:

  • Coronary artery disease

Study Name:

Jostent: Graftmaster RX Coronary Stent Graft for Commercial Use in Selected Patients Through a Humanitarian Device Exemption (HDE)

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.

Inclusion Criteria:

  • Coronary artery perforation

Exclusion Criteria:

  • Pregnant women
  • Children

Principal Investigator:

Raj Makkar, MD

Co-Investigator:

Suhail Dohad, MD

Study Coordinator and Contact:

Michelle Domingo
Phone: 310-423-3875
Email: michelle.domingo@cshs.org

Status:

Active

IRB No.:

4195

Date Last Updated:

06/15