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Clinical Study of Abdominal Aortic Aneurysm Exclusion (TALENT Abdominal)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Arizona Heart Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Arizona Heart Institute
ClinicalTrials.gov Identifier:
NCT00549432
First received: October 24, 2007
Last updated: May 14, 2009
Last verified: May 2009
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the proportion of patients who experience adverse events. [ Time Frame: During and after implantation. ] [ Designated as safety issue: No ]
  • Determine the proportion of patients who experience comorbidities and overall mortality rates. [ Time Frame: During and after implantation. ] [ Designated as safety issue: No ]

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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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00549432

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

Publications:
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.
Rose WW and CB Ernst. 1995. Abdominal aortic aneurysm. Comprehensive Ther, 21 (7):339-343.

Responsible Party: Edward B. Diethrich, MD, Arizona Heart Institute
ClinicalTrials.gov Identifier: NCT00549432     History of Changes
Other Study ID Numbers: G020149
Study First Received: October 24, 2007
Last Updated: May 14, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014