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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Arizona Heart Institute.
Recruitment status was:  Active, not recruiting
Information provided by:
Arizona Heart Institute Identifier:
First received: October 24, 2007
Last updated: May 14, 2009
Last verified: May 2009
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 Intervention
Abdominal Aortic Aneurysm
Device: TALENT Enhanced LPS Endoluminal Stent-Graft System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Abdominal Aortic Aneurysm Exclusion Using the TALENT Enhanced LPS Endoluminal Stent-Graft System

Resource links provided by NLM:

Further study details as provided by Arizona Heart Institute:

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

Estimated Enrollment: 75
Study Start Date: October 2002
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: October 24, 2007
Last Updated: May 14, 2009

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on April 26, 2017