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
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|Condition or disease||Intervention/treatment||Phase|
|Thoracic Aortic Aneurysm||Device: Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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. ]
- 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. ]
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|Contact: Russell Williams||602-266-2200 ext email@example.com|
|Contact: Anthony Forner||602-266-2200 ext firstname.lastname@example.org|
|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.|
|Principal Investigator:||Edward B Diethrich, M.D.||Arizona Heart Institute|
|Responsible Party:||Edward B. Diethrich, MD, Arizona Heart Institute|
|Other Study ID Numbers:||
|First Posted:||October 25, 2007 Key Record Dates|
|Last Update Posted:||May 15, 2009|
|Last Verified:||May 2009|
Aortic Aneurysm, Thoracic