Zilver® PTX™ Global Registry

The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Center Leipzig, Angiology, Leipzig, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

stenosis of the above-the-knee femoropopliteal artery
appropriate size and location of the lesion

Exclusion criteria

pregnant or breast feeding
failure or inability to give informed consent
simultaneously participating in another drug or device study

Treatment and study plan

Zilver® PTX™ Stent

Device

Stenting of the superfemoropopliteal artery.

Primary outcomes

Event-free Survival

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Evaluation of the Safety and Performance of the Zilver® PTX™ Drug-Eluting Stent for Treating De Novo or Restenotic Lesions of the Above-the-knee Femoropopliteal Artery

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2011
First posted: Mar 29, 2010
Registry last updated: Sep 11, 2014

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.

Published trials that share one or more normalized conditions with this study.

Completed