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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study Evaluating the Long Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)
- ClinicalTrials.gov ID
- NCT01379222
- Acronym / sponsor ID
- 10012289
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- AAA, Abdominal Aortic Aneurysm, EVAR, Endovascular aneurysm repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Study start
- Aug 2011
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Posted 4 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENGAGE PAS De Novo Subjects | Experimental | Device: Endurant Stent Graft SystemThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurant Stent Graft SystemThe 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. | Device | ENGAGE PAS De Novo Subjects |
Primary outcome
Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days)
Time frame: 5 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Schermerhorn, MD principal investigator
Beth Israel Deaconess Medical Center
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurant Stent Graft System in people with Aortic Aneurysm, Abdominal, run by Medtronic Cardiovascular at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021; AzTrials last refreshed its copy on 26 Oct 2026.