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OpenTrials
Completed

NCT Number: NCT02271529

Zilver PTX Delivery System

The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.

Completed

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Key information

Conditions

Peripheral Vascular Disease Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Frankston Hospital, Frankston, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
  • Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery

Exclusion criteria

  • Patient is < 18 years of age
  • Patient unable to complete required follow-up assessments
  • Patient unwilling to sign and date the informed consent
  • Simultaneous participation in another investigational drug or device study
  • Pregnant, breastfeeding or planning to become pregnant in the next 5 years
  • Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan

Treatment and study plan

Zilver® PTX® Drug-Eluting Peripheral Stent

Device

Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

Primary outcomes

  1. Mean Percent Change in Stent Length Upon Deployment

    Time frame: Immediately following completion of the stent placement procedure

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Zilver Paclitaxel(PTX) Thumbwheel Delivery System

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2014
Registry last updated
Feb 26, 2016

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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