Abdominal AneurysmNCT00604552

AneuRx Post Market Study in the Treatment of AAA

A study testing AneuRx Stent Graft in people with Abdominal Aneurysm, run by Medtronic Cardiovascular at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Aneurysm
What is being tested?: AneuRx Stent Graft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 349 participants
Where: 8 sitesUnited States
Study dates: Jul 2003to Feb 2009
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

Patients implanted with an AneuRx Stent Graft per Instructions for Use
Patients must provide written informed consent and agree to be accessible for follow-up at the study center.

Who cannot join

None listed.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Study site
Asheville, North Carolina
Study site
Chapel Hill, North Carolina
Study site
Memphis, Tennessee
Study site
Morristown, New Jersey
Study site
Norfolk, Virginia
Study site
Royal Oak, Michigan
Study site
Sioux Falls, South Dakota
Study site
Tucson, Arizona

Other trials in United States

About this study

Official title: AneuRx Post Market Surveillance Registry

The purpose of this study is to monitor the long term performance of the AneuRx Stent Graft Systems.

Conditions: Abdominal Aneurysm
Being tested: AneuRx Stent Graft
Keywords: Abdominal Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft
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.

AneuRx Stent GraftDevice
Abdominal Aortic Aneurysm Repair

Study groups in NCT00604552
Study group	Role	What they receive
Lifeline Registry	Other	All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS) Receives: Device: AneuRx Stent Graft
PS Registry	Other	All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic Receives: Device: AneuRx Stent Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion
Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion
Measured: 5 year

Secondary outcomes (1)

Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2003Feb 2009

First posted30 Jan 2008 (estimated)
Study startJul 2003
Primary completionFeb 2008
Study completionFeb 2009

Why it stopped: Mutual agreement between FDA closed the 522 postmarket surveillance Registry.

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 Abdominal AneurysmStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 349 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00604552
Sponsor's protocol ID: PS01000010
Status last verified: Oct 2021
First submitted: 21 Dec 2007
Last updated: 29 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

All Abdominal Aneurysm trials

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: AneuRx Post Market Surveillance Registry
ClinicalTrials.gov ID: NCT00604552
Acronym / sponsor ID: PS01000010
Conditions: Abdominal Aneurysm
Keywords: Abdominal Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft
Study type: Interventional
Recruitment status: TerminatedReason stopped: Mutual agreement between FDA closed the 522 postmarket surveillance Registry.
Enrolment: 349 participants (actual)
Lead sponsor: Medtronic CardiovascularIndustry (pharma, biotech, devices)
Collaborators: Medtronic
Study start: Jul 2003
Primary completion: Feb 2008 (actual)
Study completion: Feb 2009 (actual)
First posted: 30 Jan 2008 (estimated)
Results: Posted 30 Jul 2013

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 this study is to monitor the long term performance of the AneuRx Stent Graft Systems.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lifeline Registry	Other	Device: AneuRx Stent GraftAll comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
PS Registry	Other	Device: AneuRx Stent GraftAll comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients implanted with an AneuRx Stent Graft per Instructions for Use
Patients must provide written informed consent and agree to be accessible for follow-up at the study center.

Key exclusion criteria (0 listed)

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
AneuRx Stent GraftAbdominal Aortic Aneurysm Repair	Device	Lifeline Registry, PS Registry

Primary outcome

Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion
Time frame: 5 year
Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion

1 secondary outcome

Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events
Time frame: 5 years

Results and safety

Results posted to the registry on 30 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lifeline Registry	189	189
PS Registry	160	160

Primary outcome: Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion

Time frame: 5 year. Number. Unit: participants

Measure	Lifeline Registry n = 189	PS Registry n = 160
Death	21	20
Aneurysm Rupture	0	1
Surgical Conversion	1	2

Population analysed: All those treated on-label for the treatment of an AAA and followed out to 5 years.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lifeline Registry	0 of 189 (0%)	0 of 189 (0%)	Not reported
PS Registry	0 of 160 (0%)	0 of 160 (0%)	Not reported

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects analyzed; Technical problems with measurement leading to unreliable or uninterpretable data.

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.

Related trials for Abdominal Aneurysm

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

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.

Medtronic Cardiovascular study chair

Medtronic

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AneuRx Stent Graft in people with Abdominal Aneurysm, run by Medtronic Cardiovascular at 8 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 2 inclusion and 0 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: stopped early, 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 8 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 30 Jul 2013). 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?

Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion (time frame: 5 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00604552.

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.