AneuRx Post Market Study in the Treatment of AAA

Medtronic Cardiovascular349 enrolled

Overview

The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. Abdominal aortic aneurysm (AAA) is a life-threatening lesion that has been treated in recent year via endovascular repair. The purpose of this study is to monitor the long term performance of the AneuRx Stent Graft Systems.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

349

Conditions

Abdominal Aneurysm

Interventions

AneuRx Stent GraftDEVICE

Abdominal Aortic Aneurysm Repair

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients implanted with an AneuRx Stent Graft per Instructions for Use * Patients must provide written informed consent and agree to be accessible for follow-up at the study center.

Locations (8)

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

Royal Oak, Michigan, United States

Unnamed facility

Morristown, New Jersey, United States

Unnamed facility

Asheville, North Carolina, United States

Outcomes

Primary Outcomes

Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion

Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion

Time frame: 5 year

Secondary Outcomes

Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events

Time frame: 5 years

Data from ClinicalTrials.gov

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