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

The Cleveland Clinic1,366 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,366

Conditions

Thoracoabdominal Aneurysm Abdominal Aortic Aneurysm

Interventions

Endovascular Aneurysm RepairDEVICE

Endovascular exclusion of aneurysm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Freedom From Aneurysm Rupture

Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan

Time frame: 2 years

Data from ClinicalTrials.gov

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