Status:
COMPLETED
Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA)
Lead Sponsor:
Rodney A. White, M.D.
Conditions:
Abdominal Aortic Aneurysms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the Talent Endoluminal Spring Graft System, an investigational device, to treat abdominal aortic aneurysms (AAA). The treatment...
Detailed Description
Endovascular aneurysm repair (EVAR) offers certain advantages as compared to surgical repair of an abdominal aortic aneurysm. Known benefits associated with EVAR, as described in scientific literature...
Eligibility Criteria
Inclusion
- Subjects who participate in this study must fulfill all of the following criteria.
- Subject is \> 18 years of age.
- Subject is not pregnant, and, if female and of child-bearing potential, is practicing contraception.
- Subject has documented evidence of at least one patent internal iliac artery.
- Subject has an AAA that is dilated to \> 4 cm in diameter.
- 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 \<60o.
- Subject has renal arteries \> 9 cm from the aortic bifurcation.
- Subject has proximal and distal iliac neck diameters \> 8 mm and \< 18 mm to accommodate stock devices. For those subjects whose proximal and distal iliac diameters are \> 18 mm, custom devices with a variation in fixation diameters will be ordered from the manufacturer.
- Subject has a distal iliac neck length \> 15 mm.
- Subject has signed informed consent.
- Subject will be available for follow-up for 12 months after the procedure.
Exclusion
- Subjects who fulfill any of the following criteria may not participate in this study.
- Subject has patent internal iliac arteries that require graft extension to the external iliac arteries.
- Subject has one or more patent subrenal arteries with potential retrograde flow after stent-grafting.
- Subject has a dominant patent inferior mesenteric artery and an occluded or stenotic celiac and superior mesenteric artery.
- Subject has an aneurysm involving both internal iliac arteries.
- 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 contraindications for use of contrast medium or anticoagulation drugs.
- Subject has received a previous stent in the subrenal aorta.
- Subject has an untreatable bleeding diathesis.
- Subject is in a hypercoagulable state.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00695253
Start Date
April 1 2002
End Date
March 1 2013
Last Update
February 15 2023
Active Locations (1)
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1
LAC Harbor-UCLA Medical Center
Torrance, California, United States, 90502