search
Back to results

Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Primary Purpose

Abdominal Aortic Aneurysm, Iliac Aneurysm, Internal Iliac Aneurysm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endovascular Aneurysm Repair
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular Aneurysm Repair

Arm Description

Investigational stent-graft implant to exclude aneurysm

Outcomes

Primary Outcome Measures

Freedom From Aneurysm Rupture
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan

Secondary Outcome Measures

Full Information

First Posted
December 20, 2007
Last Updated
January 21, 2019
Sponsor
The Cleveland Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT00583414
Brief Title
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
Official Title
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 1998 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm, Iliac Aneurysm, Internal Iliac Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endovascular Aneurysm Repair
Arm Type
Experimental
Arm Description
Investigational stent-graft implant to exclude aneurysm
Intervention Type
Device
Intervention Name(s)
Endovascular Aneurysm Repair
Other Intervention Name(s)
Cook Zenith
Intervention Description
Endovascular exclusion of aneurysm
Primary Outcome Measure Information:
Title
Freedom From Aneurysm Rupture
Description
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Eagleton, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28502545
Citation
Farivar BS, Abbasi MN, Dias AP, Kuramochi Y, Brier CS, Parodi FE, Eagleton MJ. Durability of iliac artery preservation associated with endovascular repair of infrarenal aortoiliac aneurysms. J Vasc Surg. 2017 Oct;66(4):1028-1036.e18. doi: 10.1016/j.jvs.2017.02.042. Epub 2017 May 11.
Results Reference
derived
PubMed Identifier
24188715
Citation
Eagleton MJ, Shah S, Petkosevek D, Mastracci TM, Greenberg RK. Hypogastric and subclavian artery patency affects onset and recovery of spinal cord ischemia associated with aortic endografting. J Vasc Surg. 2014 Jan;59(1):89-94. doi: 10.1016/j.jvs.2013.07.007. Epub 2013 Nov 1.
Results Reference
derived

Learn more about this trial

Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

We'll reach out to this number within 24 hrs