TriVascular Post-Market Registry
- Conditions
- Abdominal Aortic Aneurysm
- Interventions
- Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 501
- 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
- Pregnancy
- Subjects with poor renal function as indicated by a serum creatinine > 2.5mg/dl.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ovation™ or Ovation Prime™ Abdominal Stent Graft System Ovation™ or Ovation Prime™ Abdominal Stent Graft System 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.
- 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)
Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
Ospedale San Raffaele
🇮🇹Milan, Italy
Università La Sapienza/Policlinico Umberto I
🇮🇹Roma, Italy
St. George's Vascular Institute
🇬🇧London, United Kingdom
Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology
🇦🇹Wien, Austria
O.L. Vrouwziekenhuis
🇧🇪Aalst, 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
Herz- und Gefässzentrum Bad Bevensen
🇩🇪Bad Bevensen, Germany
Park Hospital Leipzig, Strümpellstr. 41
🇩🇪Leipzig, Western Saxony Land, Germany
Universitäres Herz und Gefaßzentrum Hamburg
🇩🇪Hamburg, Germany
Franziskus-Krankenhaus Berlin
🇩🇪Berlin, Germany
Cardiovascular Center
🇩🇪Frankfurt, Germany
Städtisches klinikum Karlsruhe Klinik für Gefäß- und Thoraxchirurgie
🇩🇪Karlsruhe, Germany
"CA Gefäßchirurgie Theresienkrankenhaus/St. Hedwig"
🇩🇪Mannheim, Germany
Attikon Hospital
🇬🇷Athens, Greece
Policlinico San Donato
🇮🇹Milan, Italy
Ospedale Civico Palermo
🇮🇹Palermo, Italy
Ospedale Bianchi Melacrino Morelli
🇮🇹Reggio Calabria, Italy
Azienda Ospedaliera Sant'Andrea
🇮🇹Roma, Italy
Ospedale San Giovanni Addolorata
🇮🇹Roma, Italy
Univeristà La Sapienza/Policlinico Umberto I
🇮🇹Rome, Italy
Södersjukhuset
🇸🇪Stockholm, Sweden
Ospedale San Giovanni Bosco
🇮🇹Torino, Italy
A.O. Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Frimley Park Hospital NHS Foundation Trust
🇬🇧Frimley, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom