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Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by The Cleveland Clinic
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Matthew Eagleton, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00583414
First received: December 20, 2007
Last updated: April 12, 2017
Last verified: April 2017

December 20, 2007
April 12, 2017
September 1998
December 2020   (Final data collection date for primary outcome measure)
Freedom from Aneurysm Rupture [ Time Frame: 2 years ]
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
Saftey [ Time Frame: Undecided ]
Complete list of historical versions of study NCT00583414 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
  • Abdominal Aortic Aneurysm
  • Iliac Aneurysm
  • Internal Iliac Aneurysm
Device: Endovascular Aneurysm Repair
Endovascular exclusion of aneurysm
Other Name: Cook Zenith
Experimental: Endovascular Aneurysm Repair
Investigational stent-graft implant to exclude aneurysm
Intervention: Device: Endovascular Aneurysm Repair
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
450
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Nancy P Simpson 216-444-9729 simpson@ccf.org
United States
 
 
NCT00583414
G980198
IRB 3264 ( Other Identifier: Cleveland Clinic IRB )
Yes
Not Provided
No
Not Provided
Matthew Eagleton, The Cleveland Clinic
Matthew Eagleton
The Cleveland Clinic
Principal Investigator: Matthew J Eagleton, MD The Cleveland Clinic
The Cleveland Clinic
April 2017

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