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NCT00583050 Clinical Trial

Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Endovascular Exclusion of Thoracoabdominal Aortic Aneurysms or Abdominal Aneurysms Utilizing Fenestrated/Branched Stent-Grafts

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00583050
Other study ID # G010002
Secondary ID IRB 4281
Status Completed
Phase N/A
First received
Last updated
Start date February 2001
Est. completion date February 1, 2020

Study information
Verified date April 2020
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms.

Description:

The purpose of the study is to evaluate the role of fenestrated/branched stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.

Recruitment information / eligibility
Status Completed
Enrollment 1366
Est. completion date February 1, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. At least 18 years of age.

2. Not pregnant

3. Willing and able to comply with two-year follow-up period.

4. Willing and able to give informed consent prior to enrollment

5. No known allergy to stainless steel or polyester

6. No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately.

7. Life expectancy greater than two years

8. High risk candidate for open surgical repair

Exclusion Criteria:

see above

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Endovascular Aneurysm Repair
Endovascular exclusion of aneurysm

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (2)
Lead Sponsor Collaborator
The Cleveland Clinic Massachusetts General Hospital

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
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