Critical limb ischemia vascular disease
Conditions
Interventions
The Absorb everolimus-eluting BVS system (Abbott Vascular, Santa Clara,
California, USA) will be used in the endovascular treatment of symptomatic
tibial atherosclerotic lesions.
Sponsors
Maasstadziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Age >= 18 years * At least 1 symptomatic de novo or restenotic (after only PTA) atherosclerotic tibial lesion. * The lesion should be a stenosis of at least 70% or an occlusion * The maximum length of the lesion is 100mm. * At least 1 outflow artery to the foot distally to the target lesion, either direct or through collaterals. * Target vessel diameter >= 2.0 and
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * PAOD Rutherford-Becker classification 1-3 or 6. * A life expectancy less than 1 year. * Thrombus within the target lesion * Multiple stenoses in the tibial target artery * Acute limb ischemia * Dissection * Lesion length > 100mm. * Aspirin, Clopidogrel, Heparin or Everolimus allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is in-stent restenosis at 12 months, defined as lumen narrowing > 50% assessed by angiography. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Technical success rate, defined as residual stenosis | — |
Countries
Netherlands
Outcome results
None listed