Skip to main content
OpenTrials
Completed

NCT Number: NCT00583050

Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts

The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thoracoabdominal Aneurysm 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

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years of age.
  • Not pregnant
  • Willing and able to comply with two-year follow-up period.
  • Willing and able to give informed consent prior to enrollment
  • No known allergy to stainless steel or polyester
  • No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately.
  • Life expectancy greater than two years
  • High risk candidate for open surgical repair

Exclusion criteria

see above

Treatment and study plan

Endovascular Aneurysm Repair

Device

Endovascular exclusion of aneurysm

Other names: Cook Zenith

Primary outcomes

  1. Freedom From Aneurysm Rupture

    Time frame: 2 years

    Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts

Important dates

Study start
2001
Primary completion
2019
Study completion
2020
First posted
Dec 31, 2007
Registry last updated
May 8, 2020

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.

Related clinical trials

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