1 / 8

6-Month Results of the LEVANT I Trial

6-Month Results of the LEVANT I Trial. A Comparison of the Moxy™ Drug Coated Balloon Catheter vs. Standard PTA for Femoropopliteal Disease NCT# 00930813. Dierk Scheinert, Principal Investigator on behalf of the LEVANT I Investigators Heart Center Leipzig/Park Hospital, Leipzig Germany.

acacia
Download Presentation

6-Month Results of the LEVANT I Trial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 6-Month Results of the LEVANT I Trial A Comparison of the Moxy™ Drug Coated Balloon Catheter vs. Standard PTA for Femoropopliteal Disease NCT# 00930813 Dierk Scheinert, Principal Investigator on behalf of the LEVANT I InvestigatorsHeart Center Leipzig/Park Hospital, Leipzig Germany

  2. Technology overview • Proprietary 2 g/mm2 paclitaxel coating with hydrophilic non-polymeric carrier • Formulation balances drug retention during transit and uptakeupon inflation • Drug delivered during single 30 second inflation • Robust, uniform coating CAUTION: Investigational Device – Limited by Federal (USA) Law to Investigational Use

  3. LEVANT I study summary

  4. Levant I trial study design Protocol defined pre-dilation N=101 Balloon groupN=75 Stent groupN=26 1:1 1:1 PTA N=38 Moxy N=37 PTA N=14 Moxy N=12

  5. 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

  6. LEVANT I Late Lumen Loss at 6 MonthsITT Analysis N=24 N=35 N=11 N=8 N=39 N=31 Moxy PTA Moxy PTA Moxy PTA

  7. LEVANT I Conclusions *Achieved primary endpoint of improved late lumen loss Strong biologic effect demonstrated on the inhibition of neointimal hyperplasia. Data suggests the Moxy DCB is safe with a marked decrease in clinical events compared to PTA Shorter duration anti-platelet therapy appears feasible in the peripheral vasculature. Large pivotal trial is warranted to further confirm the benefit of treating SFA-popliteal lesions with a drug-coated balloon.

  8. LEVANT II Trial: Study Summary

More Related