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OpenTrials
Completed

NCT Number: NCT00196092

Zenith® AAA Endovascular Graft Clinical Study

The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

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

  • Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm.
  • Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm.
  • Patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year.

Exclusion criteria

  • Patients less than 18 years of age.
  • Patient with a life expectancy less than 2 years.
  • Patients who are pregnant.
  • Patients unwilling to comply with the follow-up schedule.
  • Patient inability or refusal to give informed consent.

Treatment and study plan

Roll-in

Device

Proctored entry.

Surgical

Device

Surgery

Standard Risk

Device

Standard Endovascular repair

High Risk

Device

High Risk Endovascular repair.

Compassionate Use

Device

Endovascular repair for compassionate use patients.

Treatment for females

Device

Endovascular repair in female patients

Standard Risk Continued Access

Device

Continued Access Endovascular repair for standard risk patients.

High Risk Continued Access

Device

Continued Access Endovascular Repair for High Risk Patients.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Important dates

Study start
2000
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Mar 12, 2015

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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