CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 178 enrolled
Drug / intervention
Endurant Stent Graft Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01379222
NCT01379222N/ACompleted
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Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)

Medtronic Cardiovascular·interventional·Posted Jun 23, 2011·Updated Oct 29, 2021

In Brief

A clinical study evaluating Endurant Stent Graft System for Aortic Aneurysm, Abdominal. Completed, enrolled 178 participants across 24 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Aneurysm, Abdominal
CountriesUnited States
CollaboratorsDuke Clinical Research Institute

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2011
Enrollment StartAug 1, 2011
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 15.0 years ago

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.