Clinical Study of Abdominal Aortic Aneurysm Exclusion (TALENT Abdominal) (l)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00549432
Recruitment Status : Unknown
Verified May 2009 by Arizona Heart Institute.
Recruitment status was:  Active, not recruiting
First Posted : October 25, 2007
Last Update Posted : May 15, 2009
Information provided by:
Arizona Heart Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: TALENT Enhanced LPS Endoluminal Stent-Graft System Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Abdominal Aortic Aneurysm Exclusion Using the TALENT Enhanced LPS Endoluminal Stent-Graft System
Study Start Date : October 2002
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Device: TALENT Enhanced LPS Endoluminal Stent-Graft System
roadmapping, and angiography for proper implant positioning. The TALENT endoluminal stent-graft endoprosthesis is inserted by delivery catheter and introducer sheath via a surgical cutdown (e.g., external iliac artery, femoral artery) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.

Primary Outcome Measures :
  1. Determine the proportion in whom successful implantation is achieved, as indicated by aneurysm exclusion and graft patency. [ Time Frame: At implant, time of discharge, and 1, 6, and 12 months. ]

Secondary Outcome Measures :
  1. Determine the proportion of patients who experience adverse events. [ Time Frame: During and after implantation. ]
  2. Determine the proportion of patients who experience comorbidities and overall mortality rates. [ Time Frame: During and after implantation. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00549432

United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
Arizona Heart Institute
Principal Investigator: Edward B Diethrich, M.D. Arizona Heart Institute

Bickerstaff LK, LH Hollier, HJ Van Peenen, et al. 1984 Abdominal aortic aneurysm: the changing natural history. J Vasc Surg, 8(2): 163-167.
Pathology of nonspecific abdominal aortic aneurysm disease. In Current Therapy in Vascular Surgery, 2nd edition, CB Ernst and JC Stanley, eds. B.C. Decker, Philadelphia, PA.
Cronenwett JL and LN Samspon. 1995. Aneurysms of the abdominal aorta and iliac arteris. In Current Diagnosis and Treatment in Vascular Surgery, 1st edition, RH Dean, JST Yao and DC Brewster, eds. Appleton and Lange, Norwalk, CT. pp 220-238.
Gloviczki P. Ruptured abdominal aortic aneurysms. In Vascular Surgery, 4th edition, Rutherford, RB, ed. Saunders, Philadelphia, PA, chapter 76.
Perler BA. 1995. Natural history of abdominal aortic aneurysm. A clinical presentation. Seventh Annual International Symposium on Vascular Diagnosis and Intervention. pp. 173-175.

Responsible Party: Edward B. Diethrich, MD, Arizona Heart Institute Identifier: NCT00549432     History of Changes
Other Study ID Numbers: G020149
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases