Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

Endologix

Status: Completed

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: Suprarenal Proximal Cuff Extension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739401

CP04-002

IDE G990139

Details and patient eligibility

About

The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old
• Informed consent understood and signed
• Will comply with post-treatment follow-up requirements up to 5 years
• Candidate for Powerlink Infrarenal Bifurcated Graft

Exclusion criteria

• Life expectancy < 2 years
• Participating in another clinical research study
• Pregnant or lactating women
• Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study
• Creatinine level > 1.7mg/dl
• Renal transplant patient
• Patient with > 75% renal artery stenosis and not eligible for PTA/stent intervention prior to suprarenal device fixation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

1

Experimental group

Description:

Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.

Treatment:

Device: Suprarenal Proximal Cuff Extension