Zenith® Low Profile AAA Endovascular Graft

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.

Completed

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Key information

Conditions

Abdominal Aortic Aneurysms Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Aortoiliac Aneurysms Cardiovascular Diseases Iliac Aneurysm Iliac Aneurysms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Zenith Low Profile AAA Endovascular Graft and ancillary components

Device

Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair

Primary outcomes

Number of Patients Without Major Adverse Events Within 30 Days

Time frame: 30 days

Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
Number of Patients With Device Success

Time frame: 12 months

Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2021
First posted: Aug 28, 2015
Registry last updated: Apr 19, 2022

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.

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

Completed