Clinical Study of Abdominal Aortic Aneurysm Exclusion (TALENT Abdominal)

Status unconfirmed · Not applicable

Conditions studied: Abdominal Aortic Aneurysm

In brief

The purpose of the study is to evaluate the TALENT endoluminal stent-graft system in patients with abdominal aortic aneurysms. The TALENT endoluminal stent-graft system is a flexible, implantable endoluminal vascular device preloaded in a placement system that is used to exclude abdominal aortic aneurysms.

Key facts

Study ID

NCT00549432

Run by

Arizona Heart Institute

People needed

75

Starts

2002-10-01

Expected to finish

2012-10-01

Last updated by the study team

2009-05-15

Who can join

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

You may qualify if…

• Subject is ≥ 18 years of age.
• Subject has a proximal AAA neck (distance between the top of the aneurysm and the renal arteries) ≥ 5 mm.
• Subject has a proximal aortic neck diameter ≥ 14 mm and ≤ 32 mm.
• Subject has an angle between the suprarenal aorta and the aneurysm ≤ 60°.
• Subject has renal arteries ≥ 9 cm from the aortic neck bifurcation.
• Subject has proximal and distal iliac neck diameters ≥ 8 mm and ≤ 24 mm.
• Subject has a distal iliac neck length ≥ 15 mm.
• Subject has signed the informed consent.
• Subject will be available for follow-up at periodic intervals after the procedure.

You may not qualify if…

• Subject has a document patent inferior mesenteric artery and an occluded or stenotic celiac and superior mesenteric artery.
• Subject has a lesion that cannot be crossed with a guide wire.
• Subject whose arterial access site cannot accommodate the delivery catheter.
• Subject has no distal vascular bed.
• Subject has systemic infection, or is suspected of having systemic infection.
• Subject has an untreatable bleeding diathesis.
• Subject is not available or is not willing to come back for periodic follow-up (surveillance) after the procedure.

Where it is running

• Arizona Heart Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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