Aortic Aneurysm, AbdominalNCT01379222
Endurant Stent Graft System Post Approval Study (ENGAGE PAS)
A study testing Endurant Stent Graft System in people with Aortic Aneurysm, Abdominal, run by Medtronic Cardiovascular at 24 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Endurant Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 24 sitesUnited States
- Study dates
- Aug 2011to Dec 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18103
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215-5324
University of Virginia Medical Center
Charlottesville, Virginia, 22908-0816
Mercy Hospital and Medical Center
Chicago, Illinois, 60616-2332
The Christ Hospital
Cincinnati, Ohio, 45219-2906
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75226-1316
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3307
Sanford Medical Center Fargo
Fargo, North Dakota, 58122
CHI Saint Luke's Health - Baylor Saint Luke's Medical Center
Houston, Texas, 77030-2604
Physicians Regional Medical Center
Knoxville, Tennessee, 37917-4556
Parkwest Medical Center
Knoxville, Tennessee, 37923-4325
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-1000
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Medical Center of Central Georgia (MCCG)
Macon, Georgia, 31201-2102
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215-3669
Morristown Memorial Hospital
Morristown, New Jersey, 07960-6136
Yale New Haven Hospital
New Haven, Connecticut, 06510-3220
University of Pittsburgh Medical Center UPMC Shadyside
Pittsburgh, Pennsylvania, 15232-1311
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610-1231
Southern Illinois University School of Medicine
Springfield, Illinois, 62702-4933
Bayfront Medical Center
St. Petersburg, Florida, 33701-4814
Stanford Hospital & Clinics
Stanford, California, 94305-5330
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103-3013
About this study
Official title: 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).
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Endurant Stent Graft System
- Keywords
- AAA, Abdominal Aortic Aneurysm, EVAR, Endovascular aneurysm repair
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| ENGAGE PAS De Novo Subjects | Experimental | 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). Receives: Device: Endurant Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic Aneurysm, AbdominalStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Marc Schermerhorn, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379222
- Sponsor's protocol ID
- 10012289
- Status last verified
- Oct 2021
- First submitted
- 21 Jun 2011
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No