Brief Title
TriVascular Post-Market Registry
Official Title
A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Brief Summary
This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.
Study Type
Observational
Primary Outcome
Treatment Success at 12 Months Post-Implantation/surgery.
Secondary Outcome
Safety and Performance Endpoints
Condition
Abdominal Aortic Aneurysm
Intervention
Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Study Arms / Comparison Groups
Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Description: Adult male and female patients will be consecutively screened for the study. Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria.
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
501
Start Date
May 2011
Completion Date
January 2019
Primary Completion Date
December 2014
Eligibility Criteria
Inclusion Criteria: - Subject is > 18 years or minimum age as required by local regulations. - Indication for elective repair of AAA with an endovascular stent graft in accordance with the Instructions for Use of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System. - Subject has signed an Ethics Committee (EC) approved Informed Consent Form. The subject or legal representative has been informed of the nature of the study, has consented to participate, and has authorized the collection and release of his/her medical information. - Subject intends to electively receive the Ovation™ or Ovation Prime™ Abdominal Stent Graft System. - Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan. Exclusion Criteria: - Subject demonstrates high probability of non-adherence to physician's follow-up requirements. - Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results. - Life expectancy less than 1 year - Pregnancy - Subjects with poor renal function as indicated by a serum creatinine > 2.5mg/dl.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01372709
Organization ID
771-0008
Responsible Party
Sponsor
Study Sponsor
TriVascular, Inc.
Study Sponsor
, ,
Verification Date
October 2016