Abdominal Aortic/Aorto-Iliac Aneurysm Endoluminal Graft Study

Status unconfirmed · Phase 2

Conditions studied: Aortic Aneurysm

In brief

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.

Key facts

Study ID

NCT00549354

Run by

Arizona Heart Institute

People needed

34

Starts

2000-08-01

Expected to finish

2012-12-01

Last updated by the study team

2015-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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)

You may not qualify if…

• 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

Where it is running

• Arizona Heart Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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