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Vessel Deformations and Restenosis After Stenting of the Popliteal Artery

NCT04700371 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-03-12

No results posted yet for this study

Summary

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.

Conditions

  • Peripheral Arterial Disease
  • Popliteal Artery Stenosis

Interventions

DEVICE

Interwoven stent

Interwoven nitinol stent placement in patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery.

DEVICE

Laser-cut stent

Laser-cut nitinol stent placement in patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery.

Sponsors & Collaborators

  • Kantonsspital Aarau

    lead OTHER

Principal Investigators

  • Aljoscha Rastan · Kantonsspital Aarau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-08-01
Completion
2024-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04700371 on ClinicalTrials.gov