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Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

Primary Purpose

Aortic Aneurysm, Abdominal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endurant Stent Graft System
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring AAA, Abdominal Aortic Aneurysm, EVAR, Endovascular aneurysm repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ronald Reagan UCLA Medical Center
  • Stanford Hospital & Clinics
  • Yale New Haven Hospital
  • Bayfront Medical Center
  • Medical Center of Central Georgia (MCCG)
  • Mercy Hospital and Medical Center
  • Southern Illinois University School of Medicine
  • Beth Israel Deaconess Medical Center
  • Dartmouth-Hitchcock Medical Center
  • Morristown Memorial Hospital
  • WakeMed Health & Hospitals
  • Novant Health Forsyth Medical Center
  • Sanford Medical Center Fargo
  • The Christ Hospital
  • University Hospitals Cleveland Medical Center
  • Lehigh Valley Hospital - Cedar Crest
  • University of Pittsburgh Medical Center UPMC Shadyside
  • Physicians Regional Medical Center
  • Parkwest Medical Center
  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
  • CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
  • University of Virginia Medical Center
  • Inova Fairfax Hospital
  • Aurora Saint Luke's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ENGAGE PAS De Novo Subjects

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 21, 2011
Last Updated
October 27, 2021
Sponsor
Medtronic Cardiovascular
Collaborators
Duke Clinical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01379222
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular
Collaborators
Duke Clinical Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal
Keywords
AAA, Abdominal Aortic Aneurysm, EVAR, Endovascular aneurysm repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ENGAGE PAS De Novo Subjects
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Endurant Stent Graft System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Schermerhorn, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Hospital & Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5330
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510-3220
Country
United States
Facility Name
Bayfront Medical Center
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701-4814
Country
United States
Facility Name
Medical Center of Central Georgia (MCCG)
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201-2102
Country
United States
Facility Name
Mercy Hospital and Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616-2332
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702-4933
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5324
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-1000
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960-6136
Country
United States
Facility Name
WakeMed Health & Hospitals
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610-1231
Country
United States
Facility Name
Novant Health Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-3013
Country
United States
Facility Name
Sanford Medical Center Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219-2906
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1716
Country
United States
Facility Name
Lehigh Valley Hospital - Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
University of Pittsburgh Medical Center UPMC Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232-1311
Country
United States
Facility Name
Physicians Regional Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917-4556
Country
United States
Facility Name
Parkwest Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923-4325
Country
United States
Facility Name
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226-1316
Country
United States
Facility Name
CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2604
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0816
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042-3307
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215-3669
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Endurant Stent Graft System Post Approval Study (ENGAGE PAS)

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