This trial is active, not recruiting.

Conditions abdominal aortic aneurysms, iliac aneurysms, aorto-iliac aneurysms
Treatment zenith low profile aaa endovascular graft
Sponsor Cook
Start date March 2011
End date June 2014
Trial size 32 participants
Trial identifier NCT02557659, 08-013 CA


This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
The Zenith Low Profile AAA Endovascular Graft and ancillary components
zenith low profile aaa endovascular graft
Treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair

Primary Outcomes

Device Success
time frame: 12 months
Freedom from Major Adverse Events (MAE)
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: •Subject has at least one of the following - Aortic or aortoiliac aneurysm - Iliac aneurysm - Aneurysm with a history of growth Exclusion Criteria: - Less than 18 years of age - Inability or refusal to give informed consent - Life expectancy less than 2 years - Pregnant of breastfeeding or planning on becoming pregnant with 60 months - Unwilling to comply with the follow-up schedule

Additional Information

Official title Clinical Investigation Plan for the Zenith® Low Profile AAA Endovascular Graft
Principal investigator Ronald Fairman, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Cook.