Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by The Cleveland Clinic
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Matthew Eagleton, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:
NCT00583414
First received: December 20, 2007
Last updated: August 10, 2015
Last verified: August 2015

December 20, 2007
August 10, 2015
September 1998
December 2020   (final data collection date for primary outcome measure)
Safety [ Time Frame: Undecided ] [ Designated as safety issue: Yes ]
Saftey [ Time Frame: Undecided ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00583414 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

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

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.

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Abdominal Aortic Aneurysm
  • Iliac Aneurysm
  • Hypogastric Aneurysm
Device: Endovascular Stent-graft Implantation
Endovascular Repair of Aortic Aneurysm
Other Name: Cook Zenith
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2020
December 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Nancy P Simpson 216-444-9729 simpson@ccf.org
United States
 
NCT00583414
G980198, IRB 3264
Yes
Matthew Eagleton, Cleveland Clinic Foundation
Matthew Eagleton
The Cleveland Clinic
Principal Investigator: Matthew J Eagleton, MD The Cleveland Clinic
The Cleveland Clinic
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP