Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Exclusion Criteria

• •Patients will be excluded from participation if ANY of the following criteria apply:
• •Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC.
• •Anatomical suitability according to CT scan.
• •Systolic Pulmonary Artery Pressure \> 65mmHg
• •Moderate or more mitral valve stenosis
• •Greater than moderate mitral valve regurgitation or aortic valve stenosis/regurgitation
• •Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation
• •Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) \< 35 ml/min/1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis
• •Liver cirrhosis or moderate or severe liver disease (Child-Turcotte-Pugh class B or C, or a score of 7 or higher)
• •Thrombocytopenia (Platelet count\< 80,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3) within 14 days of the index procedure
• •In the opinion of the Investigator or the study eligibility committee, the patient's life expectancy \< 12 months