TriVascular Post-Market Registry
This trial is active, not recruiting.
|Condition||abdominal aortic aneurysm|
|Treatment||ovation™ or ovation prime™ abdominal stent graft system|
|Start date||May 2011|
|End date||December 2014|
|Trial size||501 participants|
|Trial identifier||NCT01372709, 771-0008|
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.
Treatment Success at 12 Months Post-Implantation/surgery.
time frame: 12 Months
Safety and Performance Endpoints
time frame: 1, 6, &12 Months
Male or female participants at least 18 years old.
- 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.
- 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
- Subjects with poor renal function as indicated by a serum creatinine > 2.5mg/dl.
|Official title||A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System|
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