A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms

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Disease Information

Descriptive Information
Brief Title † A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
Official Title † A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms
Brief Summary This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to exclude the abdominal aortic aneurysm.
Detailed Description
Study Phase Phase 1
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.
Secondary Outcome Measure † Number of Participants Who Achieve Technical Success of the Stent Graft System.
Condition † Abdominal Aortic Aneurysm
Intervention † DeviceTriVascular Stent-Graft System
Study Arms / Comparison Groups Arm 1 This arm is for patient that receive the TriVascular Stent-Graft System.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 43
Start Date † February 2003
Completion Date March 2010
Primary Completion Date November 2004
Eligibility Criteria † Inclusion Criteria: - Male or infertile female - Have signed an informed consent form. - Are considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm. - at least one of the following: Abdominal aortic aneurysm >= 4.5 cm in diameter; aneurysm has increased in size by 0.5cm in last 6 months; maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment; saccular aneurysm larger than 3 cm. - Have patent iliac or femoral arteries that allow endovascular access to the aneurysmal site with a 17F Delivery Catheter. Exclusion Criteria: - A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma. - A need for emergent surgery. - contraindication to undergoing angiography. - A Thoracic aortic aneurysm that requires treatment. - Presence of thrombus or atheroma in proximal aortic neck covering > 50% of the endoluminal surface. - Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00646048
Organization ID S2106
Secondary IDs ††
Responsible Party
Study Sponsor † Boston Scientific Corporation
Collaborators ††
Investigators † Study Director: Pamela Grady, PhD, Boston Scientific Corporation
Information Provided By
Verification Date January 2011
First Received Date † March 26, 2008
Last Updated Date January 26, 2011
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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