Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

Not Applicable

Completed

• Conditions: Aorto-iliac Aneurysms; Iliac Aneurysms; Abdominal Aortic Aneurysms

• Registration Number: NCT00833924
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-02
• Primary Completion: 2011-10
• Results First Submitted: 2015-12-18
• Results First Submitted QC: 2016-01-28
• Results First Posted: 2016-01-29
• Study Completion: 2016-06
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patients With Device Failures	12-month	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.
Patients With Major Adverse Events (MAE)	30-day	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.

Trial Locations

Locations (27)

University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC; 🇺🇸 San Francisco, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Yale New Haven School of Med., Dept. of Vascular Surgery; 🇺🇸 New Haven, Connecticut, United States

University of Florida, Vascular Surgery; 🇺🇸 Gainesville, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States

Spectrum Health Butterworth; 🇺🇸 Grand Rapids, Michigan, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

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