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OpenTrials
Completed

NCT Number: NCT02254837

Zilver PTX Post-Market Study in Japan

Japanese post market clinical study of the Zilver PTX device.

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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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries

Treatment and study plan

Zilver PTX Drug-Eluting Stent

Device

Primary outcomes

  1. Occurrence of stent fracture

    Time frame: 5 years

  2. Rate of adverse events

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Oct 2, 2014
Registry last updated
Jul 12, 2019

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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