Vascular Diseases
Conditions
Brief summary
Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.
Interventions
DEVICETreatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions
Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
DEVICETreatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
Sponsors
Skane University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Critical limb ischemia RC 4-6 Lesions in superficial femoral artery and popliteal artery (p1 -p2) Target vessel 4-8mm At least I 1 vessel runoff to the foot Age \>18 years
Exclusion criteria
Pregnancy Patient disapproval Age \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from TLR (Target Lesion Revascularization) | 6 months | Fraction of study subjects without need for retreatment at treatment location |
| Open (functioning and not stenosed) vascular reconstruction (Primary Patency) | 12months | Functioning revascularization without adjunctive measures |
| Event Free Survival | 24 months | Alive without vascular events |
Outcome results
None listed