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CardioVascular and Interventional Radiology
Published in: CardioVascular and Interventional Radiology 12/2017

01-12-2017 | Clinical Investigation

Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up

Authors: Stefan Müller-Hülsbeck, Koen Keirse, Thomas Zeller, Herman Schroë, Juan Diaz-Cartelle

Published in: CardioVascular and Interventional Radiology | Issue 12/2017

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Abstract

Purpose

To report the 3-year results of the MAJESTIC first-in-human study of the Eluvia Drug-Eluting Vascular Stent System for treating femoropopliteal artery lesions.

Methods

The prospective, single-arm, multicenter clinical trial enrolled 57 patients with symptomatic lower limb ischemia (Rutherford category 2, 3, or 4) and lesions in the superficial femoral artery or proximal popliteal artery. Mean lesion length was 70.8 ± 28.1 mm, and 46% of lesions were occluded. Efficacy measures at 2 years included primary patency, defined as duplex ultrasound peak systolic velocity ratio of ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Safety monitoring through 3 years included adverse events and TLR.

Results

Primary patency was estimated as 83.5% (Kaplan–Meier analysis) at 24 months, and 90.6% (48/53) of patients maintained an improvement in Rutherford class. At 36 months, the Kaplan–Meier estimate of freedom from TLR was 85.3%. No stent fractures were identified, and no major target limb amputations occurred.

Conclusion

MAJESTIC results demonstrated long-term treatment durability among patients whose femoropopliteal arteries were treated with the paclitaxel-eluting Eluvia stent.

Level of Evidence

Level 2b, cohort study
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Metadata
Title
Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up
Authors
Stefan Müller-Hülsbeck
Koen Keirse
Thomas Zeller
Herman Schroë
Juan Diaz-Cartelle
Publication date
01-12-2017
Publisher
Springer US
Published in
CardioVascular and Interventional Radiology / Issue 12/2017
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI
https://doi.org/10.1007/s00270-017-1771-5

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