TriVascular Post-Market Registry

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.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ovation™ or Ovation Prime™ Abdominal Stent Graft System

Device

Single occurrence permanent implant of AAA device.

Primary outcomes

Treatment Success at 12 Months Post-Implantation/surgery.

Time frame: 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 outcomes

Safety and Performance Endpoints

Time frame: 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]

Sponsors and collaborators

Lead sponsor

TriVascular, Inc.

Industry

Registry information

Official study title

A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2019
First posted: Jun 14, 2011
Registry last updated: Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed