A Comparison of the Moxy™ Drug Coated Balloon Catheter vs. Standard PTA for Femoropopliteal Disease NCT# 00930813 6-MONTH RESULTS OF THE LEVANT I TRIAL.

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Presentation transcript:

A Comparison of the Moxy™ Drug Coated Balloon Catheter vs. Standard PTA for Femoropopliteal Disease NCT# MONTH RESULTS OF THE LEVANT I TRIAL Dierk Scheinert, Principal Investigator on behalf of the LEVANT I Investigators Heart Center Leipzig/Park Hospital, Leipzig Germany

Proprietary 2  g/mm 2 paclitaxel coating with hydrophilic non-polymeric carrier Formulation balances drug retention during transit and uptake upon inflation Drug delivered during single 30 second inflation Robust, uniform coating TECHNOLOGY OVERVIEW CAUTION: Investigational Device – Limited by Federal (USA) Law to Investigational Use

LEVANT I STUDY SUMMARY

PROTOCOL DEFINED PRE-DILATION N=101 LEVANT I TRIAL STUDY DESIGN BALLOON GROUP N=75 STENT GROUP N=26 MOXY N=12 PTA N=14 MOXY N=37 PTA N=38 1:1

LEVANT I 6-MONTH RESULTS OVERVIEW Primary endpoint Late 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=0.016 Secondary Endpoint Target 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

LEVANT I LATE LUMEN LOSS AT 6 MONTHS ITT ANALYSIS MOXYPTA MOXY PTA N=39 N=8 N=35 N=31 N=24 N=11

1.Strong biologic effect demonstrated on the inhibition of neointimal hyperplasia. 4.Large pivotal trial is warranted to further confirm the benefit of treating SFA-popliteal lesions with a drug-coated balloon. 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. LEVANT I CONCLUSIONS *ACHIEVED PRIMARY ENDPOINT OF IMPROVED LATE LUMEN LOSS

LEVANT II TRIAL: STUDY SUMMARY