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Completed

NCT Number: NCT01326884

Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nara Medical University, Nara, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Abdominal aortic, aorto-iliac, and iliac aneurysms of appropriate size
  • Vessels suitable for endovascular access and aneurysm repair

Exclusion criteria

  • Less than 20 years of age
  • Inability or refusal to give informed consent
  • Disease considerations that would compromise patient safety or study outcomes
  • Unsuitable arterial anatomy

Treatment and study plan

ZLP

Device

ZLP Graft

Primary outcomes

  1. Composite rate of adverse clinical/device events

    Time frame: During (day 1) and after implantation through 12 months

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

ZLP Clinical Study

Acronym: ZLP

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 31, 2011
Registry last updated
Mar 12, 2013

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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