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OpenTrials
Completed

NCT Number: NCT02171962

Zilver® PTX® in China

The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.

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Key information

Conditions

Peripheral Artery Disease 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

Beijing Anzhen Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4
  • Stenotic (>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery
  • Reference vessel diameter of 4-9 mm
  • Lesion length up to 140 mm

Exclusion criteria

  • Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure
  • Previous stent in the study vessel
  • Bypass graft with an anastomosis in the study vessel
  • Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion
  • No patent vessel of runoff

Treatment and study plan

Zilver® PTX® Drug-Eluting Peripheral Stent

Device

Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery

Primary outcomes

  1. Primary Patency as Assessed by Duplex Ultrasonography

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Evaluation of the Zilver® PTX® Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jun 24, 2014
Registry last updated
Mar 22, 2017

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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