Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex
Not Applicable
Completed
- Conditions
- Vascular Diseases
- Interventions
- Device: Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesionsDevice: Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
- Registration Number
- NCT05296031
- Lead Sponsor
- Skane University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug Eluting Stent (DES) Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions Drug Eluting Stent (DES). Zilver PTX. Bare Metal Stent (BMS) Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions Bare Metal Stent (BMS). Zilver Flex
- Primary Outcome Measures
Name Time Method Freedom from TLR (Target Lesion Revascularization) 24 months Fraction of study subjects without need for retreatment at treatment location
Open (functioning and not stenosed) vascular reconstruction (Primary Patency) 24 months Functioning revascularization without adjunctive measures
Event Free Survival 24 months Alive without vascular events
- Secondary Outcome Measures
Name Time Method