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6-MONTH RESULTS OF THELEVANT I TRIALA Comparison of theMoxy™ Drug Coated Balloon Catheter vs.Standard PTA for Femoropoplit...
TECHNOLOGY OVERVIEW                                                                                   • Proprietary 2 g/mm...
LEVANT I STUDY SUMMARY            A Prospective, Multicenter, Single            Blind, Randomized, Controlled Trial Compar...
LEVANT I TRIAL STUDY DESIGN                  PROTOCOL DEFINED                    PRE-DILATION                       N=101 ...
LEVANT I 6-MONTH RESULTS OVERVIEWPrimary endpointLate Lumen Loss objective was met.   • ITT Analysis: 0.46 mm (Moxy) vs 1....
LEVANT I LATE LUMEN LOSS AT 6 MONTHSITT ANALYSIS     2                P=0.016                            Balloon Group    ...
LEVANT I CONCLUSIONS                                                 *ACHIEVED PRIMARY 1. Strong biologic effect demonstra...
LEVANT II TRIAL: STUDY SUMMARYDESIGN           Prospective, Randomized, Multicenter, Single Blind                 Assess t...
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Levant i trial

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WASHINGTON, D.C.—Use of the MOXY paclitaxel-eluting balloon to treat stenosis of the femoropopliteal arteries beats the use of standard percutaneous transluminal angioplasty (PTA), proving a reduction in clinical events and a shorter duration of antiplatelet therapy, according to Dierk Scheinert, MD, of Herzzentrum Leipzig, in Leipzig, Germany, who presented results of the LEVANT I trial today at the 2010 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting.

http://www.cardiovascularbusiness.com/topics/vascular-endovascular/tct-levant-i-trial-shows-promise-drug-eluting-balloons-fem-pop

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Levant i trial

  1. 1. 6-MONTH RESULTS OF THELEVANT I TRIALA Comparison of theMoxy™ Drug Coated Balloon Catheter vs.Standard PTA for Femoropopliteal DiseaseNCT# 00930813Dierk Scheinert, Principal Investigatoron behalf of the LEVANT I InvestigatorsHeart Center Leipzig/Park Hospital, Leipzig Germany
  2. 2. TECHNOLOGY OVERVIEW • Proprietary 2 g/mm2 paclitaxel coating with hydrophilic non-polymeric carrier • Formulation balances drug retention during transit and uptake upon Lutonix inflationPaclitaxel Arterial Optimized Formulation • Drug delivered duringTissue Levels single 30 second inflation No Sub-Optimal Carrier Carrier • Robust, uniform coating Rate of Coating Release CAUTION: Investigational Device – Limited by Federal (USA) Law to Investigational Use
  3. 3. LEVANT I STUDY SUMMARY A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing theDESIGN Moxy™ Catheter vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries With and Without Stenting Assess the safety and efficacy of the Moxy™ CatheterOBJECTIVE for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard PTAPRIMARY Late Lumen Loss at 6 MonthsENDPOINTMAJOR TLR, TVR, Primary Patency, SafetySECONDARY
  4. 4. LEVANT I TRIAL STUDY DESIGN PROTOCOL DEFINED PRE-DILATION N=101 BALLOON STENT GROUP GROUP N=75 N=26 1:1 1:1 MOXY PTA MOXY PTA N=37 N=38 N=12 N=14
  5. 5. LEVANT I 6-MONTH RESULTS OVERVIEWPrimary endpointLate Lumen Loss objective was met. • ITT Analysis: 0.46 mm (Moxy) vs 1.09 (PTA) p=0.016 • PP Analysis: 0.36 mm (Moxy) vs 1.08 (PTA) p=0.016Secondary EndpointTarget lesion revascularization • ITT Analysis: 13% (Moxy) vs. 22% (PTA) • PP Analysis: 6% (Moxy) vs. 21% (PTA)1 month (no stent) and 3 month (stent) clopidogrel regimen •no reported incidents of acute or late thrombosis in Moxy group
  6. 6. LEVANT I LATE LUMEN LOSS AT 6 MONTHSITT ANALYSIS 2 P=0.016 Balloon Group Stent Group N=24 N=35mm N=11 N=39 1.09 N=31 1.19 N=8 0.9 0.46 0.45 0.49 0 MOXY PTA MOXY PTA MOXY PTA
  7. 7. LEVANT I CONCLUSIONS *ACHIEVED PRIMARY 1. Strong biologic effect demonstrated on ENDPOINT OF IMPROVED the inhibition of neointimal hyperplasia. LATE LUMEN LOSS 2. Data suggests the Moxy DCB is safe with a marked decrease in clinical events compared to PTA 3. Shorter duration anti-platelet therapy appears feasible in the peripheral vasculature. 4. Large pivotal trial is warranted to further confirm the benefit of treating SFA-popliteal lesions with a drug-coated balloon.
  8. 8. LEVANT II TRIAL: STUDY SUMMARYDESIGN Prospective, Randomized, Multicenter, Single Blind Assess the safety and efficacy of the Moxy Catheter forOBJECTIVE treatment of stenosis of the femoropopliteal arteries by direct comparison to standard PTA Safety: Composite of freedom from all-causePRIMARY perioperative and 1 year index limb amputation, indexENDPOINT limb re-intervention, and index-limb-related death. Efficacy: Primary Patency of the target lesion at 1 year.FOLLOW-UP To 5 yearsPRINCIPAL Kenneth Rosenfield, MD, BostonINVESTIGATORS Dierk Scheinert MD, LeipzigEXPECTED START Dec 2010 (IDE pending)

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