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

NeuroTherapia, Inc.

Status: Completed

Conditions: Thoracoabdominal Aneurysm; Abdominal Aortic Aneurysm

Treatments: Device: Endovascular Aneurysm Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT00583050

IRB 4281 (Other Identifier)

G010002

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,366 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,366 participants in 1 patient group

Endovascular Aneurysm Repair

Experimental group

Description:

Endovascular Aneurysm Repair of TAAA/AAA with Fenestrated/Branched Stent Grafts

Treatment:

Device: Endovascular Aneurysm Repair