To obtain additional data on safety and efficacy of the Express stent implantation in the treatment of stenosed or occlusive atherosclerotic disease (de novo or restenotic lesions) in the iliac arteries (common or external).
This study was conducted to provide additional data on the safety and efficacy of the Express™ Vascular LD stent, particularly with regard to the long-term patency in iliac arteries. The study would provide data on angiographic endpoints and clinical outcomes at 30 days, 6 months, and at 12 and 24 months post implantation in atherosclerotic lesions in iliac arteries. The data obtained in this study with the use of the Express™ Vascular LD stent was compared with historical data obtained from the use of the Palmaz balloon-expandable stent. The Palmaz balloon expandable stent has been chosen as the control device because it is currently the only FDA-approved balloon-expandable stent for use in the percutaneous treatment of atherosclerotic disease in iliac arteries. The Palmaz balloon-expandable stent is no longer commercialized in Europe. Therefore a randomized study with the Palmaz balloon-expandable stent was not feasible. In addition, there are no ongoing or published randomized trials describing performance of a newer version of the Palmaz stent in iliac atherosclerotic lesions. In order to adequately compare the efficacy data of the ExpressTM Vascular LD stent with the efficacy data of the Palmaz balloon-expandable stent, the same efficacy parameter as in the publication on the Palmaz balloon-expandable stent was measured in this study: % mean loss of the luminal diameter at 6 months post-procedure. The findings of the longer-term Follow-Up assessments at 12 and 24 months will be presented as the results from these assessments become available.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Limburgs Vaatcentrum Ziekenhuis Oost-Limburg
Genk, Belgium
Sint Trudo Hospital
Sint-Truiden, Belgium
CHUM- Notre Dame Hospital
Montreal, Quebec, Canada
General Teaching Hospital Prague
Angiographic mean percent loss of luminal diameter at 6 months post-procedure defined as ((post-procedure MLD - Follow-up MLD)/Post-procedure MLD) X 100
hemodynamic success at hospital discharge, 30 days and 6, 12 and 24 months post-procedure, angiographic binary restenosis at 6 mont
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Prague, Czechia
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia
Sint Antonius Hospital
Nieuwegein, CM, Netherlands
University Hospital of Krakow
Krakow, Poland
University School of Medicine
Lublin, Poland
Center of Diagnostic Imaging and Vascular Disease Treatment
Szczecin, Poland
Samodzielny Publiczny Centraln Szpital
Warsaw, Poland