Literature DB >> 20939723

Express LD vascular stent in the treatment of iliac artery lesions: 24-month results from the MELODIE trial.

Luc Stockx1, Wojciech Poncyljusz, Marek Krzanowski, Herman Schroë, Dominic J Allocco, Keith D Dawkins.   

Abstract

PURPOSE: To report the 2-year results of the MELODIE trial, which evaluated the safety and effectiveness of the balloon-expandable Express LD Vascular stent for the treatment of atherosclerotic iliac artery disease.
METHODS: This prospective, multicenter, single-arm trial enrolled 151 patients (113 men; mean age 60.1±8.4 years) with 163 de novo or restenotic iliac lesions. The primary endpoint, 6-month angiographic mean percent loss of luminal diameter, was compared to an objective performance criterion (OPC) based on published results with the Palmaz stent. Follow-up included ankle-brachial index (ABI) measurement and symptom assessment (Fontaine classification) at discharge, 30 days, and 6, 12, and 24 months. Arteriography was performed at 6 months and computed tomographic angiography (CTA) at 1 and 2 years.
RESULTS: The primary endpoint of 6-month mean percent luminal diameter loss was 16.2% (upper 95% confidence boundary of 19.1%) and non-inferior to the 20% OPC (p = 0.006). Primary patency was 92.1% at 6 months and 87.8% at 2 years. The rate of major adverse events (MAE) was 6.3% at 6 months and 10.2% at 2 years. Of the 3 event types included in the definition of MAE, only target lesion revascularization occurred; no distal embolization or device- or procedure-related deaths were recorded. The percent of patients with Fontaine stage IIb symptoms or worse improved from 84.1% before the procedure to 16.8% at 2 years (p<0.0001). The 2-year ABI remained significantly improved compared to baseline (0.85 versus 0.63, p<0.0001).
CONCLUSION: The Express LD Vascular stent is safe, effective, and non-inferior to the Palmaz stent for treatment of iliac artery stenosis.

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Year:  2010        PMID: 20939723     DOI: 10.1583/09-2917MR.1

Source DB:  PubMed          Journal:  J Endovasc Ther        ISSN: 1526-6028            Impact factor:   3.487


  3 in total

1.  Results From the VISIBILITY Iliac Study: Primary and Cohort Outcomes at 9 Months.

Authors:  John H Rundback; Patrick Peeters; Jon C George; Michael R Jaff; Peter L Faries
Journal:  J Endovasc Ther       Date:  2017-02-01       Impact factor: 3.487

Review 2.  Endovascular revascularization for aortoiliac atherosclerotic disease.

Authors:  Vikas Aggarwal; Stephen W Waldo; Ehrin J Armstrong
Journal:  Vasc Health Risk Manag       Date:  2016-03-29

3.  Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial.

Authors:  Woong Gil Choi; Seung Woon Rha; Cheol Ung Choi; Eung Ju Kim; Dong Joo Oh; Yoon Hyung Cho; Sang Ho Park; Seung Jin Lee; Ae Yong Hur; Young Guk Ko; Sang Min Park; Ki Chang Kim; Joo Han Kim; Min Woong Kim; Sang Min Kim; Jang Ho Bae; Jung Min Bong; Won Yu Kang; Jae Bin Seo; Woo Yong Jung; Jang Hyun Cho; Do Hoi Kim; Ji Hoon Ahn; Soo Hyun Kim; Ji Yong Jang
Journal:  Trials       Date:  2016-06-25       Impact factor: 2.279

  3 in total

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