Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

Medtronic Cardiovascular178 enrolled

Overview

The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through the endpoints established in this protocol. The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality (ARM).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

178

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endurant Stent Graft SystemDEVICE

The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years * Indication for elective surgical repair of abdominal aortic aneurysm (AAA) with an endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Endurant Stent Graft System * Signed consent form. The subject or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his medical information * Intention to electively implant the Endurant Stent Graft System * Ability and willingness to comply with the Clinical Investigational Plan (CIP). Exclusion Criteria: * High probability of non-adherence to physician's follow-up requirements * Current participation in a concurrent trial which may confound study results * Female of childbearing potential in whom pregnancy cannot be excluded or who is lactating.

Locations (24)

Outcomes

Primary Outcomes

Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days)

Aneurysm-Related Mortality (ARM) is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should be aneurysm related. \> All deaths will be adjudicated by a Clinical Events Committee (CEC) to determine device, procedure and/or AAA relatedness.

Time frame: 5 years

Data from ClinicalTrials.gov

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