Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent

Exclusion Criteria

• •1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
• •2. Impaired renal function (serum creatinine \>2. mg/dL or 150 μmol/l);
• •3. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a WBC \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis);
• •4. Presence of a heart transplant
• •5. Known allergy to cobalt chromium
• •6. Hypersensitivity or contraindication to cobalt-chromium or structurally-related compounds, cobalt, chromium, nickel, or tungsten
• •7. Anticipated use of rotational artherectomy
• •8. Patient in whom the use of a drug eluting stent is contraindicted, e.g., who cannot receive the recommended dual anti-platelet (aspirin and an approved P2Y12 inhibitor) and/or anticoagulant therapy
• •9. Left main coronary artery disease (protected and unprotected);
• •10. Trifurcation lesion;
• •11. Totally occluded target vessels (TIMI flow 0 or 1);
• •12. Moderate to Severely calcified target lesion(s);
• •13. Highly calcified target lesion(s) requiring rotational atherectomy;
• •14. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
• •15. Angiographic evidence of thrombus in the target lesion(s);
• •16. Tryton Stent placement without angioplasty pre-dilatation of the main branch and side branch (i.e., direct stenting is contraindicated)
• •17. Tryton Stent placement alone, without implantation of a main branch stent
• •18. An untreated significant (\>50%) stenosis proximal or distal in either the side branch or main branch;
• •19. Impaired runoff in the treatment vessel with diffuse distal disease;
• •20. Left ventricular ejection fraction (LVEF) 30% (LVEF must be obtained within 6 months prior to the index procedure); -