Peripheral Arterial Disease
Conditions
Keywords
peripheral arterial disease, drug-eluting balloon, restenosis
Brief summary
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed versus conventional balloon angioplasty in superficial femoral artery and popliteal artery re-stenosis.
Interventions
Sponsors
Leonardo Bolognese, MD
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age\>18 years * intermittent claudication (Fontane III or IV) * angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm, previously treated with nitinol stent implantation, with at least one below-knee vessel to the ankle
Exclusion criteria
* allergy to Paclitaxel * contraindication for combined antiplatelet treatment * life expectancy \<1 year * hypersensitivity or contraindication to one of the study drugs * lack of consent * need for amputation * angiographic evidence of stent fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| angiographic binary re-restenosis | 12 months | incidence of angiographic binary re-restenosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| major amputation | 24 months | incidence of major amputation |
| stent thrombosis | 24 months | incidence of stent thrombosis |
| target lesion revascularization | 24 months | incidence of target lesion revascularization |
Countries
Italy
Outcome results
None listed