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FRONTIER Registry

FRONTIER Registry. The Guidant MULTI-LINK FRONTIER ™ Coronary Stent System for the Treatment of Pts with Native De Novo or Restenotic Bifurcation Coronary Artery Lesions. T. Lefèvre and W. Van der Giessen On Behalf the FRONTIER Investigators. Objective.

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FRONTIER Registry

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  1. FRONTIER Registry The Guidant MULTI-LINK FRONTIER™ Coronary Stent System for the Treatment of Pts with Native De Novo or Restenotic Bifurcation Coronary Artery Lesions T. Lefèvre and W. Van der Giessen On Behalf the FRONTIER Investigators

  2. Objective • To assess the safety, procedural success, performance and 6month clinical outcome of bifurcation stenting • To evaluate angiographic results and 6 month incidence of TSR • With the use of the Guidant MULTI-LINK FRONTIER Coronary Stent System in patients with de novo or restenotic bifurcation lesions

  3. Study design • Prospective, non randomized • 100 patients • Up to 2 lead in patients per site • 13 sites - Europe, New Zealand • Clinical Follow-up • In-hospital, 30 days and 6 months • Angiography • Pre and Post-Procedure • 6 months

  4. Guidant MUTI-LINK FRONTIER™ Coronary Bifurcation Stent System Specially designed dual lumen tip • Designed for preserving side branch access • Integrated-tip design allows single tip delivery, avoiding wire wrap • Stent deploys with simultaneous “kissing balloon inflation” • Wire position is maintained in both branches throughout the procedure Main Branch (RX) Side Branch (OTW)

  5. Guidant ML FRONTIER™ Coronary Bifurcation Stent System • Sizes • Stent length – 18mm (main branch) • 7 Fr. GC Compatible

  6. Guidant MULTI-LINK FRONTIER™ Deployment Technique Two balloons. Two wires. One very special stent. “Provisional T stenting” strategy

  7. ML FRONTIER™ Deployment Sequence Guidant MULTI-LINK FRONTIER™ Deployment Technique Self rotation when out of phase

  8. Primary endpoints • Incidence of MACE* at 6 monthsfollow-up * Hierarchical occurrence of Death, Q-wave and non-Q-wave MI, Target Lesion Revascularization (main branch and/or side branch) including PTCA and CABG

  9. Secondary endpoints • Incidence of MACEat 30 days follow up • Angiographic binary restenosis rate at 6 months • Access site complications • TVF at one and six months follow up • TVR at six monthsfollow up • Acute success of stent delivery, deployment, and post dilatation

  10. Key Inclusion Criteria • Other lesions in different epicardial vessel successfully treated prior to bifurcation procedure • Native or restenotic (no stent) vessel suitable to receive a 2.5 to 4.0 mm ML FRONTIER Stent • Target main branch vessel is a major coronary artery with estimated stenosis > 50 and < 100% • Angle of bifurcation < 75 • Main branch lesion suitable for a total stent length of < 31mm by visual estimate • Appropriate lesion morphology

  11. Key Exclusion Criteria • Untreated lesion >50% proximal or distal to target lesion • Target lesion contains thrombus • Target lesion is aorto-ostial or left main stem location • Target lesion or proximal vessel has excessive tortuosity unsuitable for stent delivery • Heavy or severe calcification

  12. Enrolling Sites (n= 11)

  13. FRONTIER Trial Enrollment

  14. Baseline Demographics(Intent-to-treat patient population)

  15. Baseline QCA Analysis(Intent-to-treat patient population) * Cardialysis, Rotterdam, The Netherlands

  16. A B C Parent Vessel Only Prebranch 7.9% 24.8% 13.9% Postbranch D E F Prebranch and Ostial Bifurcation 5.9% 36.6% Ostial 10.9% Bifurcation Lesion Classification(Intent-to-treat patient population) Cardialysis, Rotterdam, The Netherlands

  17. Procedural data in Main Branch(Intent-to-treat patient population) * Stent did not cross (8/9), twisted wire (1/9)

  18. Procedural data in Main Branch(Intent-to-treat patient population) * Stent did not cross (8/9), twisted wire (1/9) ** 1 reason unknown Caution: Investigational device. Limited by Federal (US) law to investigational use only. Not available for sale

  19. Procedural data in Main Branch(Per protocol patient population) Cardialysis, Rotterdam, The Netherlands

  20. Procedural data in Side Branch(Per protocol patient population) Cardialysis, Rotterdam, The Netherlands

  21. QCA Analysis(Per-protocol patient population) Cardialysis, Rotterdam, The Netherlands

  22. QCA Analysis(Per-protocol patient population)

  23. MACE(intent-to-treat patient population) Hierarchical Ranking

  24. Sample calculation (MACE) • StudyAlphaRatenLower Limit Upper Limit • Finci et al0.0537.4%9127.4% 48.1% • Yamashita et al0.0537.8%3722.5%55.2% • Finci et ali 0.0562.2%4546.5%76.2% • Yamashita et al0.0550.9%5336.8%64.9% • Lefèvre et al0.0529.1%18217.5%36.3% • Karvouni et al0.0548.4%6235.5%61.4% • Al Suwaidi et al 0.0526.8%7517.1%38.1% • Al Suwaidi et al0.0547.7%5132.9%61.5% • Wt. Avg 29.5% 51.2 %

  25. Conclusion This new stent specifically designed for treating bifurcation lesions and preserving side branch access can be used with a high procedural success rate. • Compared to previous studies with workhorse stents, the clinical outcome as well as acute angiographic and 6-months results are very encouraging.

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