Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
2 other identifiers
interventional
120
5 countries
27
Brief Summary
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2008
Longer than P75 for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 30, 2009
CompletedFirst Posted
Study publicly available on registry
February 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedResults Posted
Study results publicly available
January 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedApril 4, 2018
March 1, 2018
3.4 years
January 30, 2009
December 18, 2015
March 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patients With Major Adverse Events (MAE)
MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.
30-day
Patients With Device Failures
Device success at 12-month is defined as: Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.
12-month
Study Arms (1)
1
OTHERTreatment with Endovascular Graft
Interventions
The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
Eligibility Criteria
You may qualify if:
- Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
- Vessels suitable for endovascular access and aneurysm repair
You may not qualify if:
- Less than 18 years of age
- Inability or refusal to give informed consent
- Disease considerations that would compromise patient safety or study outcomes
- Unsuitable arterial anatomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC
San Francisco, California, 94143, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Yale New Haven School of Med., Dept. of Vascular Surgery
New Haven, Connecticut, 06510, United States
University of Florida, Vascular Surgery
Gainesville, Florida, 32610, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
Spectrum Health Butterworth
Grand Rapids, Michigan, 49546, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63141, United States
Mercy Hospital
St Louis, Missouri, 63141, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07960, United States
New York University Hospital
New York, New York, 10016, United States
New York Presbyterian Hospital - Cornell
New York, New York, 10032, United States
University of Rochester, Strong Memorial Hospital
Rochester, New York, 14642, United States
University of North Carolina
Chapel Hill, North Carolina, 27955, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Fairfax Inova Hospital
Falls Church, Virginia, 22042, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Queen Mary Hospital
Hong Kong, China
St. Franziskus Hospital
Münster, 48145, Germany
CELT Hospital
Moscow, 111123, Russia
Malmo University Hospital
Malmo, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scott Snyder, PhD, Director of Clinical Science & Biostatistics
- Organization
- Cook Research Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Fairman, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 30, 2009
First Posted
February 2, 2009
Study Start
May 1, 2008
Primary Completion
October 1, 2011
Study Completion
June 1, 2016
Last Updated
April 4, 2018
Results First Posted
January 29, 2016
Record last verified: 2018-03