The SirPAD trial is an academic, investigator-initiated, single-center, randomized, non-inferiority, open-label clinical trial investigating whether the use of sirolimus-coated balloon catheters in patients with peripheral artery disease of the femoro-popliteal or below-the-knee segment is not inferior to that of uncoated balloon catheters for major clinical outcomes (unplanned major amputation, target limb re-vascularization) and may provide advantages concerning important secondary outcomes, which will be evaluated using a pre-specified hierarchical order as part of the primary analysis.
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The primary efficacy outcome is a composite of two major adverse limb events (MALE): unplanned major amputation of the target limb or endovascular/surgical target lesion re-vascularization for critical limb ischemia occurring within one year.
Timeframe: One year