Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583414
• Other study ID #: G980198
• Secondary ID: IRB 3264
• Status: Completed
• Phase: N/A
• Start date: September 1998
• Est. completion date: October 2017

Study information

• Verified date: January 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Iliac Aneurysm
• Internal Iliac Aneurysm

Intervention

Device:
• Endovascular Aneurysm Repair
Endovascular exclusion of aneurysm

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From Aneurysm Rupture	Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan	2 years