Clinical trial NCT01379222: Endurant Stent Graft System Post Approval Study (ENGAGE PAS)
Official title: Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Keywords: AAA
Abdominal Aortic Aneurysm
EVAR
Endovascular aneurysm repair
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
First posted: 2011-06-23
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Saint Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Macon
country: United States
facility: Medical Center of Central Georgia (MCCG)
state: Georgia
city: Chicago
country: United States
facility: Mercy Hospital and Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Medical Center Fargo
state: North Dakota
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital - Cedar Crest
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Shadyside
state: Pennsylvania
city: Knoxville
country: United States
facility: Physicians Regional Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: Parkwest Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Marc Schermerhorn, MD
role: PRINCIPAL_INVESTIGATOR
References: