Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

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

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 Overview

• Status: Completed
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Device: Endurant Stent Graft System

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Stanford, California, United States, 94305-5330
      • Stanford Hospital & Clinics
  • Connecticut
    • New Haven, Connecticut, United States, 06510-3220
      • Yale New Haven Hospital
  • Florida
    • Saint Petersburg, Florida, United States, 33701-4814
      • Bayfront Medical Center
  • Georgia
    • Macon, Georgia, United States, 31201-2102
      • Medical Center of Central Georgia (MCCG)
  • Illinois
    • Chicago, Illinois, United States, 60616-2332
      • Mercy Hospital and Medical Center
    • Springfield, Illinois, United States, 62702-4933
      • Southern Illinois University School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5324
      • Beth Israel Deaconess Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-1000
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Morristown, New Jersey, United States, 07960-6136
      • Morristown Memorial Hospital
  • North Carolina
    • Raleigh, North Carolina, United States, 27610-1231
      • WakeMed Health & Hospitals
    • Winston-Salem, North Carolina, United States, 27103-3013
      • Novant Health Forsyth Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Medical Center Fargo
  • Ohio
    • Cincinnati, Ohio, United States, 45219-2906
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44106-1716
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital - Cedar Crest
    • Pittsburgh, Pennsylvania, United States, 15232-1311
      • University of Pittsburgh Medical Center UPMC Shadyside
  • Tennessee
    • Knoxville, Tennessee, United States, 37917-4556
      • Physicians Regional Medical Center
    • Knoxville, Tennessee, United States, 37923-4325
      • Parkwest Medical Center
  • Texas
    • Dallas, Texas, United States, 75226-1316
      • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
    • Houston, Texas, United States, 77030-2604
      • CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908-0816
      • University of Virginia Medical Center
    • Falls Church, Virginia, United States, 22042-3307
      • Inova Fairfax Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215-3669
      • Aurora Saint Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ENGAGE PAS De Novo Subjects; The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Collaborators: Duke Clinical Research Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: June 21, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 23, 2011

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: AAA; EVAR; Endovascular aneurysm repair; Abdominal Aortic Aneurysm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 10012289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes