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Completed

NCT Number: NCT01348425

Zilver PTX Drug-Eluting Peripheral Stent Study

This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis 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

Herz-Zentrum, Bad Krozingen, 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
  • Reference vessel diameter of 4 - 9 mm
  • Rutherford category ≥ 2
  • Resting ankle brachial index < 0.9

Exclusion criteria

  • Prior stent in the study vessel
  • Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure
  • Lacks at least one patent runoff vessel
  • Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery

Treatment and study plan

Longer Zilver PTX Stents

Device

Treatment with at least one 100 mm or longer Zilver PTX stent

Shorter Zilver PTX Stents

Device

Treatment with Zilver PTX stents 80 mm or shorter only

Primary outcomes

  1. Percent Change in Stent Length Upon Deployment

    Time frame: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 5, 2011
Registry last updated
Feb 2, 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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