Arterial Occlusive Disease, Atherosclerotic Disease, Intermittent Claudication, Thrombosis
Conditions
Keywords
iliac arteries, implantation, treatment of atherosclerotic disease, stenosed, occlusive
Brief summary
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).
Detailed description
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 In addition, there are no ongoing or published randomized trials describing performance of a newer version of the Palmaz stent in iliac atherosclerotic lesions.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.
Interventions
DEVICEstent implantation
Sponsors
KIKA
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* chronic symptomatic atherosclerotic disease in the iliac arteries (Fontaine Class IIa, IIb, and III) * atherosclerotic de novo or restenotic lesions in the common and/or external iliac artery. * baseline diameter stenosis of \> or = 50% * reference vessel diameter \> or = 5mm and \< or = 10mm * at least one sufficient ipsilateral infrapopliteal run-off * length of diseased segment(s) \< or = 10cm and can be treated with maximally two overlapping Express Vascular LD Stents. * multiple target lesions of the iliac arteries in the same patient can be included provided if each target lesion is compliant with the antiographic inclusion criteria and non-compliant with any of the antiographic
Exclusion criteria
, target lesions are not located in the same target axis, and all target lesions can be treated during the same procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| hemodynamic success at hospital discharge, 30 days and 6, 12 and 24 months post-procedure, angiographic binary restenosis at 6 mont | — |
Countries
Belgium, Canada, Czechia, Netherlands, Poland
Outcome results
None listed