To investigate whether the use of sirolimus-coated balloon catheters in patients with lower extremity peripheral artery disease is non-inferior to the use of uncoated balloon catheters in terms of unplanned major amputation or revascularization.
Aim of the study
It is being investigated whether the dilation of the vasoconstriction using a drug-coated balloon catheter is as good or better than with an uncoated balloon catheter.
Who can take part?
Patients for whom a balloon dilation of a blocked leg artery is planned
Procedure
The SirPAD trial is an academic, investigator-initiated, randomized, non-inferiority, open-label clinical trial investigating whether a sirolimus-coated balloon catheter is non-inferior to uncoated balloon catheters in terms of the occurrence of serious clinical events (unplanned major amputation, target lesion revascularization) in the treatment of patients with peripheral arterial occlusive disease of the femoro-popliteal or transtibial segment. If non-inferiority is confirmed, it is examined whether the intervention has advantages with regard to important secondary clinical outcomes (predefined superiority analysis). A total of 1,200 all-comer consecutive patients will be recruited over 3.5 years at 2 centers (Zurich-USZ and Fribourg).
Original study name
Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty
BASEC number
2020-00080