Peripheral arterial disease (PAD) in the legs or lower extremities is the narrowing or blockage of the vessels that carry blood from the heart to the legs. It is primarily caused by the buildup of fatty plaque in the arteries, which is called atherosclerosis. PAD can happen in any blood vessel, but it is more common in the legs than the arms.
The following investigator-initiated study has been launched at the Department of Angiology and is sponsored by the University of Zurich:
- SirPAD phase III trial (NCT04238546): Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Un-coated Balloon Angioplasty. The SirPAD trial is an academic, investigator-initiated, 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 lesion revascularization). If non-inferiority is confirmed, it will be tested whether the intervention provides advantages concerning important secondary clinical outcomes (predefined superiority analysis). A total of 1,200 all-comer patients will be recruited at 2 centers (Zurich-USZ and Fribourg) over 3.5 years. Sponsor: University of Zurich. Status: recruiting.
The Department of Angiology is involved in the design and conduction of the following multinational studies:
- IN PACT BTK phase III trial (NCT02963649): Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions. Sponsor: Medtronic. Status: recruitment completed.
XATOA phase IV trial (NCT03746275): Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid. The study enrolled adult patients suffering from coronary artery disease or peripheral artery disease, and treated with rivaroxaban 2.5 mg twice daily (Xarelto vascular) in addition to aspirin. Sponsor: Bayer. Status: recruitment completed.