Zenith® Low Profile AAA Endovascular Graft

Not Applicable

Completed

• Conditions: Iliac Aneurysms; Abdominal Aortic Aneurysms; Aortoiliac Aneurysms

• Registration Number: NCT02535065
• Lead Sponsor: Cook Research Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-27
• Study First Posted: 2015-08-28
• Primary Completion: 2017-01-23
• Results First Submitted: 2018-04-11
• Results First Submitted QC: 2018-05-03
• Results First Posted: 2018-06-06
• Study Completion: 2021-01-27
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Patients Without Major Adverse Events Within 30 Days	30 days	Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
Number of Patients With Device Success	12 months	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

Trial Locations

Locations (37)

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

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States

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

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

Iowa Heart Center; 🇺🇸 West Des Moines, Iowa, United States

Baptist Health Louisville; 🇺🇸 Louisville, Kentucky, United States

Massachusetts General; 🇺🇸 Boston, Massachusetts, United States

Scroll for more (27 remaining)