TriVascular Post-Market Registry

Completed

• Conditions: Abdominal Aortic Aneurysm

• Registration Number: NCT01372709
• Lead Sponsor: TriVascular, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-14
• Primary Completion: 2014-12-12
• Study Completion: 2019-06-14
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 \[1 \& 6 m, \& annual through 5 years\]

Trial Locations

Locations (30)

Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology; 🇦🇹 Wien, Austria

O.L. Vrouwziekenhuis; 🇧🇪 Aalst, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

Flanders Medical Research Program; 🇧🇪 Dendermonde, Belgium

Universiteit Gent; 🇧🇪 Gent, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Groupe Hospitalier Edouard Herriot; 🇫🇷 Lyon, France

Hôpital Paul d'Egine; 🇫🇷 Paris, France

Park Hospital Leipzig, Strümpellstr. 41; 🇩🇪 Leipzig, Western Saxony Land, Germany

Herz- und Gefässzentrum Bad Bevensen; 🇩🇪 Bad Bevensen, Germany

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