UnknownPhase 2

Abdominal Aortic/Aorto-Iliac Aneurysm Endoluminal Graft Study

United States34 participantsStarted 2000-08

Plain-language summary

The Bifurcated PowerLink System is intended to provide a permanent alternative conduit for blood flow within a patient's abdominal vascular system, which excludes the aneurysmal sac from blood flow and pressure.

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: * ≥ 18 years old * Informed consent understood and signed * Will comply with post-treatment follow-up requirements * Candidate for conventional open surgical repair Anatomic Inclusion Criteria: * Aneurysm is ≥ 4.0 cm in outer diameter or Saccular aneurysm ≥ 3.0 cm in outer diameter or Aneurysm ≥ twice the normal aortic outer diameter or rapidly growing aneurysm (≥ 5 mm over 6 months) Exclusion Criteria: * Life expectancy \< 2 years * Participating in another clincal research study * Pregnant or lactating women * Acutely ruptured or leaking aneurysm, or vascular injury due to trauma * Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study. * Contrast medium or anticoagulation drugs are contraindicated * Coagulopathy or bleeding disorder * Active systemic or localized groin infection * Inferior mesenteric artery is indispensable * Connective tissue disease (e.g. Marfan's Syndrome) * Creatinine level \> 1.7 mg/dl * Thrombus at implantation sites

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

Mortality Rate

Timeframe: one year

Major complications: myocardial infarction, coronary intervention, respiratory failure, aneurysm rupture, kidney failure, stroke or death

Timeframe: one year

Trial details

NCT IDNCT00549354

SponsorArizona Heart Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Aortic Aneurysm 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.