Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
501 participants
OBSERVATIONAL
2011-05-31
2019-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Single occurrence permanent implant of AAA device.
Interventions
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Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Single occurrence permanent implant of AAA device.
Eligibility Criteria
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Inclusion Criteria
* 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'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.
18 Years
ALL
No
Sponsors
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TriVascular, Inc.
INDUSTRY
Responsible Party
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Locations
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Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology
Vienna, , Austria
O.L. Vrouwziekenhuis
Aalst, , Belgium
Imelda Ziekenhuis
Bonheiden, , Belgium
Flanders Medical Research Program
Dendermonde, , Belgium
Universiteit Gent
Ghent, , 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
Franziskus-Krankenhaus Berlin
Berlin, , Germany
Cardiovascular Center
Frankfurt, , Germany
Universitäres Herz und Gefaßzentrum Hamburg
Hamburg, , Germany
Städtisches klinikum Karlsruhe Klinik für Gefäß- und Thoraxchirurgie
Karlsruhe, , Germany
"CA Gefäßchirurgie Theresienkrankenhaus/St. Hedwig"
Mannheim, , Germany
Attikon Hospital
Athens, , Greece
Ospedale San Raffaele
Milan, , Italy
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
Università La Sapienza/Policlinico Umberto I
Roma, , Italy
Univeristà La Sapienza/Policlinico Umberto I
Rome, , Italy
Ospedale San Giovanni Bosco
Torino, , Italy
A.O. Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Södersjukhuset
Stockholm, , Sweden
Frimley Park Hospital NHS Foundation Trust
Frimley, , United Kingdom
St. George's Vascular Institute
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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Other Identifiers
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771-0008
Identifier Type: -
Identifier Source: org_study_id
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