Abdominal Aortic Aneurysm
Conditions
Keywords
abdominal, aortic, aneurysm
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.
Interventions
DEVICEOvation™ or Ovation Prime™ Abdominal Stent Graft System
Single occurrence permanent implant of AAA device.
Sponsors
TriVascular, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success at 12 Months Post-Implantation/surgery. | 12 Months | The primary endpoint is treatment success at 12 months post-implantation/surgery. Treatment success is defined as a composite technical endpoint composed of successful introduction and deployment of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System at the initial implantation procedure along with clinical endpoints of absence from type I or III endoleaks, aneurysm expansion, aneurysm rupture, conversion to open surgical repair, graft migration, and graft occlusion at 12 months post-implantation procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Performance Endpoints | 1, 6, &12 Months | * Freedom from type I and III endoleaks \[1 & 6 m, & annual through 5 years\] * Freedom from aneurysm rupture \[6 m, & annual through 5 years\] * Freedom from aneurysm related mortality \[1 month\] * Freedom from aneurysm expansion \[6 m, & annual through 5 years\] * Freedom from stent graft migration \[6 m, & annual through 5 years\] * Freedom from loss of device patency \[1 & 6 m, & annual through 5 years\] * Freedom from aneurysm-related secondary endovascular procedures \[1 & 6 m, & annual through 5 years\] * Freedom from device related adverse events \[1 & 6 m, & annual through 5 years\] |
Countries
Austria, Belgium, France, Germany, Greece, Italy, Sweden, United Kingdom
Outcome results
None listed