Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  High-risk Patients With Complex Coronary Artery Disease
• Age: Between 18 Year(s) - 90 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Subjects have chronic coronary syndrome (CCS) or Non-ST-Elevation Myocardial Infarction (NSTEMI) with an Left ventricular ejection fraction (LVEF) = 40%
  OR
  2. Subject has STEMI (ST-Segment Elevation Myocardial Infarction) =24 hours and <30 days after symptom onset with an LVEF =30%
  3. Local heart team (interventional cardiologist and cardiac surgeon) has determined that percutaneous coronary intervention (PCI) is indicated and is the most appropriate management for the patient
  4. Complex PCI will be performed:
     • One of the following must be must:
       • Triple vessel disease is present, OR
       • Left main distal bifurcation or trifurcation disease, OR
       • Left main equivalent disease with both ostial LAD and ostial LCX having visually-assessed angiographic DS =80% and requiring intervention in both branches OR
       • Intervention of the last remaining vessel
     • Multivessel disease is present and PCI is planned of at least 2 separate complex lesions in main vessels or branch vessels each having one or more of the following characteristics:
       • Long lesion
       • Severe angiographic calcification or requiring atheroablation
       • Any left main morphology not in Criterion A requiring intervention
       • Non-left main bifurcation lesion requiring intervention in both the main branch and side branch
       • CTO (TIMI 0 Flow)
       • Giant thrombus (length =3x vessel diameter)
       • SVG (other than focal (<5 mm) disease of the proximal or distal anastomosis or in-stent restenosis)
  5. Subject or legal guardian provides informed, written consent

  
  

You may not be eligible for this study if the following are true:

• 1. STEMI =24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g.,VSD, papillary muscle rupture, etc.)
  2. Cardiogenic shock
  3. Subject is presently or recently intubated for the current admission
  4. Cardiorespiratory arrest related to the current admission unless subject is extubated for >24 hours with full neurologic recovery and hemodynamically stable
  5. Any contraindication or inability to Impella placement in both the left and right common femoral artery based on clinical or imaging findings, including iliofemoral artery diameter <5 mm, tortuous vascular anatomy or severe bilateral peripheral vascular disease of the iliac or femoral arteries that can’t be adequately treated (e.g., with intravascular lithotripsy)