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NCT02535065 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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Recruiting NCT05004051 - ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA