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Lesion Coverage: Insights from the Bench Top | Maciej Lesiak, M.D.

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TCT2015 Presentation - Maciej Lesiak, M.D.

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Lesion Coverage: Insights from the Bench Top | Maciej Lesiak, M.D.

  1. 1. Lesion Coverage: Insights from the Bench Top Maciej Lesiak Department of Cardiology University Hospital in Poznan, Poland
  2. 2. Disclosure Statement of Financial Interest • Grant/Research Support • Consulting Fees/Honoraria • Abbott Vascular • Abbott Vascular, AstraZeneca, Biotronik, Boston Scientific Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company
  3. 3. Bifurcation Lesions: Last large lesion subset not routinely treated with a stent 1st strategy Bifurcations Treated with Tryton
  4. 4. Bifurcation Lesions are Common “All Comers” Studies % Patients % Lesions Leaders Trial1,2 29.1% 21.6% Nobori 23 17.5% 16.9% xSearch4 22.2% N/A Average 22.9% 19.3% 1. Windecker et al. Lancet 2008; 372: 1163–73 2. Wykrzykowska, EuroPCR ’09 3. Danzi, EuroPCR ‘09 4. Serruys, ACC ‘08
  5. 5. Bifurcation Lesions Still a Challenge • Require more time, anxiety, skill, and equipment (cost) • Increased complications peri-procedural MIs, stent thrombosis, and restenosis • Suboptimal angiographic outcomes (esp. side branch ostium)
  6. 6. Tryton Side Branch Stent™ Main Branch Zone & wedding band 8mm *: 5.5mm for Large Vessel diameters **: 18mm for Large Vessel diameters Total stent length: 19mm** Transition Zone Scaffolding at the Ostium 4.5mm Side Branch Zone Secures the Side Branch 6.5mm*
  7. 7. Position Tryton Stent Straddling Side Branch Origin Proximal mid marker in MB and distal mid marker in SB
  8. 8. Bifurcation Lesions Large Angle & Diameter Variation Wide Narrow Angle Large Difference Small Difference Diameter
  9. 9. Wide Angle As Good as it Gets Too Distal Too Proximal Why the need for a Dedicated Stent: Angle Variation - ‘T’ Stent Provides Inadequate Coverage
  10. 10. Narrow Angle As Good as it Gets Too Distal Too Proximal Difficult to rescue: Lost Side Branch/MI Poor Coverage: Restenosis Why the need for a Dedicated Stent: Angle Variation - ‘T’ Stent Provides Inadequate Coverage
  11. 11. Crush Technique J. Ormiston
  12. 12. Nordic II: Localization of In-Stent Restenosis at 8-Month Follow-up
  13. 13. Competitive Bifurcation Design Strategies Balloon Expandable Self-Expanding  Cappella MainVesselSideBranch  Tryton  Devax - Axxess  Stentys  Petal  Frontier  Invatec  TriReme  Minvasys
  14. 14. Competitive Bifurcation Design Strategies Balloon Expandable Self-Expanding  Cappella MainVesselSideBranch  Tryton  Devax - Axxess  Stentys  Petal  Bioss  Frontier  Invatec  TriReme  Minvasys No Focus on Bifurcation Not on the Market
  15. 15. Bifurcation Lesions: Defining The Need  Ease-of-Use  Tracking (Single Wire)  Equipment (Operator’s Choice) – Guide Catheters (5 or 6 Fr) – Guidewires  Compatibility: any workhorse stent (DES or BMS) USER ISSUES
  16. 16. Bifurcation Lesions: Defining The Need • Coverage • Radial Strength • Addresses all anatomies (diameters, angulations)  Ease-of-Use  Tracking (Single Wire)  Equipment (Operator’s Choice) – Guide Catheters (5 or 6 Fr) – Guidewires  Compatibility: any workhorse stent (DES or BMS) USER ISSUES CLINICAL REQUIREMENTS
  17. 17. 2005 Early Design for a Crushable Stent Proximal extreme position Distal extreme position TEST DATA: Monday, 24 January 2005 (45 degree acrylic) model) POSITION RELATIVE TO CORINA: ~3mm Proximal extreme Distal extreme
  18. 18. Tryton Side Branch Stent Current Design Wedding Band
  19. 19. Bench Testing Used to Drive Design
  20. 20. Tryton Porcine Explants Demonstrate Complete Corinal Coverage Tryton Demonstration of Anatomical Fit and Coverage
  21. 21. Expansion range >3.5 mm >4.5 mm
  22. 22. Dynamic Fatigue Testing Used to evaluate long-term dimensional and structural integrity Successful at 400+ Million Cycles (10 year implant life)  Main Vessel and Tryton Stent/Strut Fracture Demonstration of Anatomical Fit, Coverage, & Durability
  23. 23. Large Vessel Difference Baseline Final
  24. 24. Small Vessel Difference Pre Final
  25. 25. Wide Angle Pre Final
  26. 26. Narrow Angle Pre Final
  27. 27. Conclusion • Tryton stent was designed to accommodate variations in vessel caliber and angle while providing main vessel stent-like scaffolding to the ostium and side branch. • Successful bench and animal testing supports the development of Tryton stent. • Outstanding in vitro results have been confirmed in daily clinical practice.
  28. 28. THANK YOU!

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