TerminatedNot Applicable

The STAPLE International Post-Market Registry

Stopped: Medtronic terminated the study since Foretevo product was no longer marketed

Canada, Germany, Greece108 participantsStarted 2010-08

Plain-language summary

The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient ≥ 18 years old
. Patient has given written informed consent
. Patient has a life expectancy \> 1 year
. Patient is willing to comply with follow-up evaluations
. Patient's AAA meets at least one of the following criteria:
. Patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm
. Patient has a proximal aortic neck length of at least 12mm
. Patient has a patent iliac or femoral artery that allows endovascular access to the aneurysmal site with 16Fr (5.3mm) or 18Fr (6.0mm) delivery system.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Technical Success

Timeframe: Within 24 hours of the Index procedure

Major Adverse Events (MAE)

Timeframe: Within 1-Month of Implantation

Trial details

NCT IDNCT01276249

SponsorMedtronic Cardiovascular

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-04

View on ClinicalTrials.gov More Aortic Aneurysm, Abdominal trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient ≥ 18 years old
. Patient has given written informed consent
. Patient has a life expectancy \> 1 year
. Patient is willing to comply with follow-up evaluations
. Patient's AAA meets at least one of the following criteria:
. Patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm
. Patient has a proximal aortic neck length of at least 12mm
. Patient has a patent iliac or femoral artery that allows endovascular access to the aneurysmal site with 16Fr (5.3mm) or 18Fr (6.0mm) delivery system.

The STAPLE International Post-Market Registry

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

The STAPLE International Post-Market Registry

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria