New device to treat severe coronary calcifications during stenting

Trial ID:
IRB-25-8511
Matthew J Price, M.D.

Inclusion Criteria

Patients must:

  • Be =18 years of age
    Have been diagnosed with native coronary artery disease including stable angina or following stabilization after acute coronary syndromes (ACS) for non-emergent percutaneous coronary intervention (PCI)
    Have an estimated life expectancy of more than 1 year.
    Have a new lesion that has not previously been treated with any interventional procedure
    Be diagnosed with severe stenosis and moderate-to-severe calcification in an untreated vessel

Exclusion Criteria

Patients must not:

  • Be pregnant or nursing at time of enrollment
    Be unable to tolerate dual antiplatelet/anticoagulation therapy
    Have chronic renal disease with eGFR less than 30
    Have a history of Transient Ischemic Attack (TIA) or stroke within the previous 60 days
    Have an active peptic ulcer or GI bleed within the past 3 months
    Have coagulopathy with platelets < 100,000 or INR > 1.7, or a hypercoagulable disorder such as polycythemia vera
    Have uncontrolled severe hypertension (>180/110)
    Have undergone non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within previous 30 days
    Anticipate any planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the study procedure

Contact Info:

  • Clinical Research Services
  • CRSLeadership@scrippshealth.org
  • 858-824-5249