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  • STENTYS Coronary Stent System Clinical Trial in Subjects with ST Elevated Myocardial Infarction (STEMI)


  • Principal Investigator: Paul Gordon, MD

    Inclusion Criteria:
    • Subject experiencing clinical symptoms consistent with AMI of >30 min. in duration.
    • ST elevation ≥1 mm in ≥2 contiguous leads or new left bundle branch block, or true posterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads.
    • Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.
    Exclusion Criteria:
    • A previous coronary interventional procedure of any kind within 30 days prior to the procedure
    • Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or emergency IABP for hypotension).
    • The subject requires multi-vessel PCI at time of index procedure or any staged procedure of the target vessel within 9 months or any non-target vessel within 30 days post-procedure.
    • Multi-vessel intervention required during the index procedure.
    Key points:
    • Device: STENTYS BMS: A self-expanding bare metal nickel titanium alloy (nitinol) stent on a rapid exchange (RX) delivery system compared to the Multi- Link BMS coronary stent platform
    • Randomized 2:1
    • Subjects will be followed for 12 months
    Contact Information:
    Cardiovascular Research
    The Miriam Hospital
    Lori-Ann DeSimone
    401-793-4105