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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ovation™ or Ovation Prime™ Abdominal Stent Graft System | Device | Single occurrence permanent implant of AAA device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success at 12 Months Post-Implantation/surgery. | 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. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Performance Endpoints |
|
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Inclusion Criteria:
Exclusion Criteria:
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The Ovation™ or Ovation Prime™ Abdominal Stent Graft System study is a multicenter, prospective, observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study intends to expand the clinical evidence of the safety and performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in an all comers ("real world") patient population.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology | Vienna | Austria | ||||
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| 1, 6, &12 Months |
| 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 | 04289 | 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 |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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