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Trial record 10 of 101 for:    "thoracic aortic aneurysms and aortic dissections" OR "Aortic Aneurysm, Thoracic"

Clinical Study of Thoracic Aortic Aneurysm Exclusion (Valiant)

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ClinicalTrials.gov Identifier: NCT00549315
Recruitment Status : Unknown
Verified May 2009 by Arizona Heart Institute.
Recruitment status was:  Recruiting
First Posted : October 25, 2007
Last Update Posted : May 15, 2009
Sponsor:
Information provided by:
Arizona Heart Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Thoracic Aortic Aneurysm Device: Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Thoracic Aortic Aneurysm Exclusion Using the VALIANT System
Study Start Date : October 2002
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




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. ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): 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

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.
Skeens JL and MD Dake. 1997. Thoracic aortic aneurysm stent-grafts. Eighth Complex Peripheral Angioplasty Course. Paris, May 20-23, 1997, pp. 289-295.

Responsible Party: Edward B. Diethrich, MD, Arizona Heart Institute
ClinicalTrials.gov Identifier: NCT00549315     History of Changes
Other Study ID Numbers: G020150
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009

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