Clinical trial NCT02535065: Zenith® Low Profile AAA Endovascular Graft
Official title: Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysms
Iliac Aneurysms
Aortoiliac Aneurysms
Keywords: Low Profile
Abdominal Aortic Aneurysms
Endovascular
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2015-08-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Patients Without Major Adverse Events Within 30 Days
timeFrame: 30 days
measure: Number of Patients With Device Success
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Royal Oak
country: United States
facility: Wm Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Columbia
country: United States
facility: Missouri Heart Center
state: Missouri
city: Saint Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Billings
country: United States
facility: St. Vincent's Heart and Vascular Center
state: Montana
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University - Langone Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Stony Brook
country: United States
facility: SUNY at Stony Brook Hospital
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Akron
country: United States
facility: Summa Akron
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan-Trihealth
state: Ohio
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital-Memphis
state: Tennessee
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Seattle
country: United States
facility: University of Washington-Harborview Medical Center
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Center
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Wausau
state: Wisconsin
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
References: