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Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Eluting Stent (DES) | Active Comparator | Drug Eluting Stent (DES). Zilver PTX. |
|
| Bare Metal Stent (BMS) | Placebo Comparator | Bare Metal Stent (BMS). Zilver Flex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from TLR (Target Lesion Revascularization) | Fraction of study subjects without need for retreatment at treatment location | 6 months |
| Freedom from TLR (Target Lesion Revascularization) | Fraction of study subjects without need for retreatment at treatment location | 12 months |
| Freedom from TLR (Target Lesion Revascularization) | Fraction of study subjects without need for retreatment at treatment location | 24 months |
| Open (functioning and not stenosed) vascular reconstruction (Primary Patency) | Functioning revascularization without adjunctive measures | 12months |
| Open (functioning and not stenosed) vascular reconstruction (Primary Patency) | Functioning revascularization without adjunctive measures | 24 months |
| Event Free Survival | Alive without vascular events | 24 months |
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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
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| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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
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| Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions | Device | 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 |
|