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Completed

NCT Number: NCT02936622

Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses

This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.

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Key information

Conditions

Peripheral Arterial Disease (PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Hochsauerland, Arnsberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • One de novo or restenosed artherosclerotic lesion with ≥ 50% diameter stenosis
  • Symptoms of peripheral arterial disease (Rutherford 2-4)

Exclusion criteria

  • Pregnant, breastfeeding, or planning to become pregnant in the next 5 years
  • Less than 18 years old
  • Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
  • Previous stent in the study vessel

Treatment and study plan

Zilver® Paclitaxel-Eluting Peripheral Stent

Device

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Device

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating

Device

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Primary outcomes

  1. The percent diameter stenosis within the study lesion evaluated by conventional angiography.

    Time frame: 6 months

    Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Acronym: XPEDITE

Important dates

Study start
2017
Primary completion
2019
Study completion
2023
First posted
Oct 18, 2016
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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