Atherosclerosis of the superficial femoral artery
Conditions
Interventions
The intervention group will undergo endovascular dilatation of intermediate and
long lesions of the SFA with the LegFlow® Paclitaxel eluting balloon followed
by placement of a nitinol selfexpandable
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age over 18 - Symptomatic, atherosclerotic intermediate (>5 cm and 15 cm) lesions of the superficial femoral artery. - Rutherford class 2-6 - At least one patent below-the-knee artery with uninterrupted flow to the pedal arch. - Signed informed consent - Randomization will be performed after advancement of a guide wire across the target SFA lesion with use of an automated web-based randomization tool.
Exclusion criteria
Exclusion criteria: - Life expectancy less than one year. - Previous endovascular or surgical treatment of the target superficial femoral artery - Inability to comply with the follow-up schedule. - Mental disability that hinders the ability to understand and comply with the informed consent. - Pregnancy or breast-feeding. - Severe renal failure (e-GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is absence of binary restenosis rate. Main study parameters are age, gender, relevant co-morbidity, and several disease and procedure related parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are reoclusion rate, target-lesion revascularization rate, clinical success, hemodynamic success, major amputation rate, complication rate, mortality rate and cost-effectiveness. , | — |
Countries
Netherlands
Outcome results
None listed