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| Name | Class |
|---|---|
| University of Patras | OTHER |
| University Hospital of Crete | OTHER |
| University Hospital, Alexandroupolis | OTHER |
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This is a Hellenic Registry including both retrospective and prospective subjects receiving the Ovation Alto™ Abdominal Stent Graft System ("Ovation Alto™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation Alto™ Hellenic Registry is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation Alto™ Abdominal Stent Graft System in actual clinical practice during the first post-operative year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group/Cohort | Ovation Alto™ Abdominal Stent Graft System Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ovation Alto™ Abdominal Stent Graft System | Device | Single occurrence permanent implantation of AAA device |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment success | Treatment success is defined as technical success, freedom from type I and III endoleaks at 12 months, freedom from stent graft migration > 10m at 12 months compared to 1 month baseline, freedom from AAA enlargement >5mm at 12 months (compared to 1-month baseline, freedom from AAA rupture through 12 months, freedom from conversion to open repair through 12 months, stent graft stenosis, occlusion or kink requiring secondary intervention through 12 months, thromboembolic event attributable to stent graft requiring secondary intervention through 12 months, stent fracture requiring secondary intervention through 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Classification of Endoleaks | Endoleak type Ia and Ib and III | 1 and 12 months |
| Stent Graft Migration | Any proximal caudal Stent Graft Migration >10mm |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated electively with Ovation Alto™ Abdominal Stent Graft System for Endovascular Aneurysm Repair
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Konstantinos Spanos, PhD | Contact | 00306948570321 | spanos.kon@gmail.com | |
| Athanasios Giannoukas, Prof | Contact | 00306944724146 | agiannoukas@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Larisssa | Recruiting | Larissa | 41110 | Greece |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 1 and 12 months |
| Abdominal aortic aneurysm sac enlargement | Any sac enlargement > 5mm | 1 and 12 months |
| Aortic neck alteration | Any neck diameter increase at supra-renal part of the aorta (at 0mm, 10mm and 20mm above the highest renal artery), and infra-renal part of the aorta (at 0mm, 7mm, and 15mm below the lowest renal artery). Measurements of the aortic neck angulation will also be included | 1 and 12 months |
| Freedom from abdominal aortic aneurysm rupture | Recording of any abdominal aortic aneurysm rupture that takes place during the follow up after the procedure in order to assess freedom from this adverse event | 1 and 12 months |
| Number of Secondary Interventions | Any secondary intervention stent-graft related including: proximal extension with a balloon expandable covered stent; stent graft extension distally to common iliac arteries; use of onyx for Endoleak Ia; bare metal stent in external iliac arteries | 1 and 12 months |
| AAA-related mortality | Any aneurysm related mortality | 1 and 12 months |
| Device-related Adverse Events (AEs) | Device-related Adverse Events: loss of latency, stent fracture, migration, Endoleak type I and III | 1 and 12 months |
| Major adverse events | Including death, myocardial infarction, stroke, chronic renal disease, stent graft infection, amputation | 1 and 12 months |
| Adherence to instruction for use | Recording of patients in terms of adherence to instructions for use according to the device manual | 12 months |
| D001018 |
| Aortic Diseases |