Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

January 21, 2019 updated by: Federico Ezequiel Parodi, The Cleveland Clinic
The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, non-randomized evaluation of endovascular aneurysm repair in high-risk patients. The purpose of this study is to determine whether this endovascular prosthesis is safe and effective for the intended use of treating AAA/iliac aneurysm in patients who are at high risk for standard aneurysm surgical repair. Up to 400 patients will be enrolled at the Cleveland clinic Foundation. Baseline procedures may include angiogram, intravascular ultrasound, CT scan, physical exam, blood work and ankle-brachial index. The endovascular prosthesis is placed in the operating room under regional or general anesthesia and the procedure length is approximately 2-3 hours. Follow up evaluations will be done at 1 month, 6 months (if clinically necessary), 12 months and yearly, and may include a physical exam, CT scan, KUB, ultrasound, blood work, and an ankle-brachial index.

Study Type

Interventional

Enrollment (Actual)

401

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The aneurysm is >/= 5 cm or larger, or with a high risk of rupture due to its shape, history of growth, symptoms, or the presence of a large (>2 cm) iliac aneurysm
  • Anticipated mortality greater than 10 percent with conventional surgery
  • Life expectancy greater than 2 years
  • Suitable arterial anatomy
  • Absence of systemic disease or allergy that precludes an endovascular repair
  • Capable of giving informed consent and willingness to comply with the follow-up schedule

Exclusion Criteria:

  • Pregnancy
  • History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately
  • Allergy to stainless steel or polyester
  • Unwilling to comply with the follow-up schedule
  • Serious or systemic groin infection
  • Coagulopathy, other than coumadin therapy
  • Inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endovascular Aneurysm Repair
Investigational stent-graft implant to exclude aneurysm
Device: Endovascular Aneurysm Repair
Endovascular exclusion of aneurysm
Other Names:
  • Cook Zenith

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Aneurysm Rupture
Time Frame: 2 years
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Matthew J Eagleton, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 1998

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G980198
  • IRB 3264 (Other Identifier: Cleveland Clinic IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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