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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
Sponsor: Nils Kucher
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2020-11-03
Completion Date
2029-12-31
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
sirolimus-coated balloon catheter
angioplasty with sirolimus-coated balloon catheter
uncoated balloon catheter
angioplasty with uncoated balloon catheter
Locations (2)
University hospital zurich
Zurich, Canton of Zurich, Switzerland
HFR Fribourg - Hôpital Cantonal / Kantonsspital
Fribourg, Switzerland