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Completed

NCT Number: NCT02571907

PRESERVE-Zenith® Branch Endovascular Graft-Iliac Bifurcation Clinical Study

The purpose of this extended study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients in a treatment of aortoiliac and iliac aneurysms.

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Key information

Conditions

Aortoiliac Aneurysms Aneurysm Cardiovascular Diseases Iliac Aneurysm Iliac Aneurysms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Foundation for Medical Education and Research, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • An aortioiliac or iliac aneurysm
  • An unsuitable distal sealing site for a traditional Zenith iliac leg graft within the common lilac artery

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, breast-feeding or planning on becoming pregnant prior to completion of the study
  • Unwilling or unable to comply with the follow-up schedule
  • Simultaneously participating in another investigative device or drug study

Treatment and study plan

Zenith® Branch Endovascular Graft-Iliac Bifurcation,

Device

Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.

Other names: Branch Graft

Atrium iCAST™

Device

Implantation of Atrium iCAST

Zenith® Flex AAA Endovascular Graft

Device

Implantation of the Zenith Flex Endovascular Graft

Primary outcomes

  1. Number of Patients With Freedom From Patency-related Intervention Defined as a Secondary Intervention to Treat a > 60 % Stenosis of the Internal Iliac Artery Associated With Clinical Symptoms.

    Time frame: 6 months

Secondary outcomes

  1. Freedom From Morbidity (i.e., Morbidity Index)

    Time frame: 30 days

    Morbidity index based on a composite endpoint of 31 pre-specified measure elements in seven categories (i.e., cardiovascular, pulmonary, renal, bowel, wound, neurologic, and vascular).

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation

Important dates

Study start
2014
Primary completion
2015
Study completion
2020
First posted
Oct 8, 2015
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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