Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

Abdominal Aortic Aneurysms Clinical Trial

Official title:

Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833924
• Other study ID #: 08-013
• Secondary ID: 370016
• Status: Completed
• Phase: N/A
• First received: January 30, 2009
• Last updated: March 8, 2018
• Start date: May 2008
• Est. completion date: June 2016

Study information

• Verified date: March 2018
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2016
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size

• Vessels suitable for endovascular access and aneurysm repair

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

• Unsuitable arterial anatomy

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aorto-iliac Aneurysms
• Iliac Aneurysm
• Iliac Aneurysms

Intervention

Device:
• Zenith(R) Low Profile AAA Endovascular Graft
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.

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong
Germany	St. Franziskus Hospital	Munster
Russian Federation	CELT Hospital	Moscow
Sweden	Malmo University Hospital	Malmo
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Fairfax Inova Hospital	Falls Church	Virginia
United States	University of Florida, Vascular Surgery	Gainesville	Florida
United States	Spectrum Health Butterworth	Grand Rapids	Michigan
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Yale New Haven School of Med., Dept. of Vascular Surgery	New Haven	Connecticut
United States	New York Presbyterian Hospital - Cornell	New York	New York
United States	New York University Hospital	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester, Strong Memorial Hospital	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Mercy Hospital	Saint Louis	Missouri
United States	University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC	San Francisco	California
United States	Harborview Medical Center	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Cook Group Incorporated

Countries where clinical trial is conducted

United States,  China,  Germany,  Russian Federation,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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