Popliteal Artery Stenosis clinical trials

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NCT ID: NCT04700371 Withdrawn - Clinical trials for Peripheral Arterial Disease

Vessel Deformations and Restenosis After Stenting of the Popliteal Artery

FIRESTEP

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The femoro-popliteal (FP) artery is the most frequently treated vascular segment in patients with symptomatic peripheral artery disease (PAD), for which endovascular therapy became an established treatment option during the last decades. However, loss of primary patency and consecutive clinically driven target lesion revascularization (TLR) limit this procedure. Moreover, in the popliteal artery (PA), evidence about the best treatment strategy to prevent loss of patency and TLR is limited to only a few randomized controlled trials (RCT). Arterial deformations of the PA with its unique anatomical properties during leg flexion might explain the poor technical and clinical outcomes in this segment. Generally, a "leave nothing behind" strategy in the PA is preferred, but cannot be avoided in all cases due to e.g. flow limiting dissections or re-coil after balloon angioplasty. Basically two different self-expandable nitinol-based stent designs are available on the market. An interwoven nitinol and laser-cut nitinol stent. The interwoven nitinol stent has a higher radial force in comparison to the laser-cut stent and reveals higher patency rates in the FP arteries. However, a head-to-head comparison of these stents is missing and it remains unknown in which way different stent designs affect the deformation and hemodynamic behaviors of the PA during knee flexion.