Peripheral Artery Disease
Conditions
Keywords
femoropopliteal lesions
Brief summary
To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty
Interventions
Sponsors
Ospedale San Donato
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* intermittent claudication or critical limb ischemia * de novo stenosis ≥ 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries * presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk * presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis \>70%)
Exclusion criteria
* life expectancy \<1 year * contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel * need for major amputation (MA) at the time of enrolment * Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major amputation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| angiographic binary restenosis | 12 months | incidence of binary restenosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite of all cause mortality, major amputation and target lesion revascularization. | 12 months | incidence of composite endpoint of all cause mortality, major amputation and target lesion revascularization. |
Countries
Italy
Outcome results
None listed