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 by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.
Interventions
DEVICEpaclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
DEVICEnitinol stent implantation
nitinol stent implantation
Sponsors
Leonardo Bolognese, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| angiographic binary restenosis | 12 months | incidence of binary restenosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| major amputation | 24 months | incidence of major amputation |
| target lesion revascularization | 24 months | incidence of target lesion revascularization |
| vessel reocclusion | 24 months | incidence of vessel reocclusion |
Countries
Italy
Outcome results
None listed