Zenith® Low Profile AAA Endovascular Graft

Abdominal Aortic Aneurysms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535065
• Other study ID #: 08-013 Spiral-Z
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: January 27, 2021

Study information

• Verified date: March 2022
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 27, 2021
• Est. primary completion date: January 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortoiliac Aneurysms
• Iliac Aneurysm
• Iliac Aneurysms

Intervention

Device:
• 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

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
United States	Summa Akron	Akron	Ohio
United States	Piedmont Hospital	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Bend Memorial Clinic	Bend	Oregon
United States	St. Vincent's Heart and Vascular Center	Billings	Montana
United States	Massachusetts General	Boston	Massachusetts
United States	Cooper University Hospital	Camden	New Jersey
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Good Samaritan-Trihealth	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Missouri Heart Center	Columbia	Missouri
United States	University of Florida	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	Borgess Research Institute	Kalamazoo	Michigan
United States	Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Baptist Health Louisville	Louisville	Kentucky
United States	Baptist Memorial Hospital-Memphis	Memphis	Tennessee
United States	New York University - Langone Medical Center	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Vascular Specialists	Norfolk	Virginia
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Wm Beaumont Hospital	Royal Oak	Michigan
United States	St. John's Mercy Medical Center	Saint Louis	Missouri
United States	University of Washington-Harborview Medical Center	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California
United States	SUNY at Stony Brook Hospital	Stony Brook	New York
United States	SUNY Upstate	Syracuse	New York
United States	Washington Hospital Center	Washington	District of Columbia
United States	Aspirus Wausau	Wausau	Wisconsin
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Without Major Adverse Events Within 30 Days	Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation	30 days
Primary	Number of Patients With Device Success	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	12 months