Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379222
• Other study ID #: 10012289
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: December 2017

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Endurant Stent Graft System
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.

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	Mercy Hospital and Medical Center	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Baylor Jack and Jane Hamilton Heart and Vascular Hospital	Dallas	Texas
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Sanford Medical Center Fargo	Fargo	North Dakota
United States	CHI Saint Luke's Health - Baylor Saint Luke's Medical Center	Houston	Texas
United States	Parkwest Medical Center	Knoxville	Tennessee
United States	Physicians Regional Medical Center	Knoxville	Tennessee
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Medical Center of Central Georgia (MCCG)	Macon	Georgia
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	University of Pittsburgh Medical Center UPMC Shadyside	Pittsburgh	Pennsylvania
United States	WakeMed Health & Hospitals	Raleigh	North Carolina
United States	Bayfront Medical Center	Saint Petersburg	Florida
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Stanford Hospital & Clinics	Stanford	California
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiovascular	Duke Clinical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years