Clinical Study of Thoracic Aortic Aneurysm Exclusion (Valiant)

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  Recruiting
Sponsor:
Information provided by:
Arizona Heart Institute
ClinicalTrials.gov Identifier:
NCT00549315
First received: October 24, 2007
Last updated: May 14, 2009
Last verified: May 2009
  Purpose

The Valiant stent-graft system is a flexible, implantable vascular stent-graft endoluminal device preloaded in a delivery system that is used to exclude thoracic aortic lesions (thoracic aneurysms, thoracic dissections, penetrating ulcers, traumatic transections and both traumatic and degenerative pseudoaneurysms.


Condition Intervention
Thoracic Aortic Aneurysm
Device: Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter

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 Thoracic Aortic Aneurysm Exclusion Using the VALIANT 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: Yes ]
  • 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: 60
Study Start Date: October 2002
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter
VALIANT stent-graft endoprosthesis is inserted by the Xcelerant Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) 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 to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is ≥ 18 years of age.
  • Subject is not pregnant or lactating. Females of child-bearing potential must practice a reliable method of contraception.
  • Subject is diagnosed with one of the following conditions of the descending thoracic aorta. All conditions must be verified by diagnostic imaging [ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI) or angiography].

    • A true (i.e., atherosclerotic) supraceliac aneurysm (fusiform or saccular type) with or without a co-existing aortic dissection or penetrating aortic ulcer;
    • Aortic dissection of DeBakey Type I or II (Stanford A, proximal) in the absence of an aneurysm; or
    • Penetrating aortic ulcer in the absence of an aneurysm; or
    • Traumatic transection; or
    • Pseudoaneurysm - traumatic or degenerative (i.e., one that does not involve all layers of the vessel and is not atherosclerotic in origin.
  • Subject's anatomy is suitable for placement of the TALENT endoluminal stent-graft, with a distinct proximal aneurysm neck of 10 mm or more in length and a distal aneurysm neck of at least 10 mm.
  • Subject has a TAA that is dilated to ≥ 5 cm in diameter, ≥ 1.5 times the diameter of the adjacent native/non-aneurysmal aorta, or is symptomatic.
  • Subject has a proximal and distal aortic neck diameter ≥ 18 mm and ≤ 42 mm.
  • Subject has an arterial access site, either peripherally or via infrarenal abdominal aorta that is adequate for introduction of the stent-graft delivery system.
  • Subject has signed the informed consent.
  • Subject will be available for the periodic follow-up (surveillance) after the procedure.
  • Aortic.

Exclusion Criteria:

  • Subject has TAA with less than 10 mm proximal fixation length.
  • Subject has an aneurysm that would require exclusion by the stent-graft of the segment of the aorta that gives rise to dominant spinal cord/intercostal arteries.
  • Subject has a lesion that prevents delivery or expansion of the device.
  • Subject has systemic infection, or is suspected of having systemic infection.
  • Subject has a known mycotic aneurysm.
  • Subject is not available or is not willing to come back for periodic follow-up (surveillance) after the procedure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549315

Contacts
Contact: Russell Williams 602-266-2200 ext 3604 rwilliams@azheart.com
Contact: Anthony Forner 602-266-2200 ext 3620 tforner@azheart.com

Locations
United States, Arizona
Arizona Heart Institute Recruiting
Phoenix, Arizona, United States, 85006
Principal Investigator: Edward B Diethrich, M.D.         
Sub-Investigator: Julio Rodriguez-Lopez, M.D.         
Sub-Investigator: Venkatesh Ramaiah, M.D.         
Sub-Investigator: Mitar Vranic, D.O.         
Sub-Investigator: Rajagopalan Ravi, M.D.         
Sponsors and Collaborators
Arizona Heart Institute
Investigators
Principal Investigator: Edward B Diethrich, M.D. Arizona Heart Institute
  More Information

Publications:
Coselli JS, S Buket, and ES Crawford. 1996. Thoracic aortic aneurysms. In: Haimovicis Vascular Surgery, 4th ed, H Haimovici, E Ascer, LH Hollier, DE Strandness, and JB Towne, eds. Blackwell Science, chapter 57.
Coselli JS and SA LeMaire. 1995. Diseases of the thoracic aorta. In: Current Diagnosis and Treatment in Vascular Surgery, 1st ed, RH Dean, JST Yao, and DC Brewster, eds. Appleton & Lange, Norwalk, CT, chapter 11.
Pressler V and JJ McNamara. 1980. Thoracic aortic aneurysm: natural history and treatment. J Thorac Cardiovasc Surg, 79: 489-498.

Responsible Party: Edward B. Diethrich, MD, Arizona Heart Institute
ClinicalTrials.gov Identifier: NCT00549315     History of Changes
Other Study ID Numbers: G020150
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, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on April 17, 2014