Overview

This trial is active, not recruiting.

Conditions abdominal aortic aneurysms, iliac aneurysms, aorto-iliac aneurysms
Treatment zenith(r) low profile aaa endovascular graft
Sponsor Cook
Start date May 2008
End date October 2012
Trial size 120 participants
Trial identifier NCT00833924, 08-013, 370016

Summary

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

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

Primary Outcomes

Measure
Composite rate of adverse clinical/device events
time frame: during and after implantation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size - Vessels suitable for endovascular access and aneurysm repair Exclusion Criteria: - Less than 18 years of age - Inability or refusal to give informed consent - Disease considerations that would compromise patient safety or study outcomes - Unsuitable arterial anatomy

Additional Information

Official title Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
Principal investigator Ronald Fairman, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Cook.