Brief Title
Zenith® Low Profile AAA Endovascular Graft
Official Title
Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft
Brief 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.
Study Type
Interventional
Primary Outcome
Number of Patients Without Major Adverse Events Within 30 Days
Condition
Abdominal Aortic Aneurysms
Intervention
Zenith Low Profile AAA Endovascular Graft and ancillary components
Study Arms / Comparison Groups
Endovascular Graft
Description: The Zenith Low Profile AAA Endovascular Graft and ancillary components
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
62
Start Date
August 2014
Completion Date
January 27, 2021
Primary Completion Date
January 23, 2017
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02535065
Organization ID
08-013 Spiral-Z
Responsible Party
Sponsor
Study Sponsor
Cook Research Incorporated
Study Sponsor
, ,
Verification Date
March 2022