Overview

This trial is active, not recruiting.

Conditions abdominal aortic aneurysms, iliac aneurysms, aortoiliac aneurysms
Treatment zenith low profile aaa endovascular graft and ancillary components
Sponsor Cook
Start date August 2014
End date January 2017
Trial size 62 participants
Trial identifier NCT02535065, 08-013 Spiral-Z

Summary

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial 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, aortoiliac, 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
(Experimental)
The Zenith Low Profile AAA Endovascular Graft and ancillary components
zenith low profile aaa endovascular graft and ancillary components
Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair

Primary Outcomes

Measure
Freedom from major adverse events
time frame: 30 days
Device success
time frame: 12 months

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 - Disease considerations that would compromise patient safety or study outcomes - Pregnant of breastfeeding or planning on becoming pregnant with 60 months - Unwilling to comply with the follow-up schedule

Additional Information

Official title Clinical Study 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 August 2016.
Information provided to ClinicalTrials.gov by Cook.