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The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenestrated Endografting | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventana Fenestrated Stent Graft System | Device | Endovascular repair of juxtarenal or pararenal aortic aneurysm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Number of Major Adverse Events (MAEs) | Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc | 30 Days |
| Feasibility- Number of subjects with procedural success (stent graft patency) and absence of type I/III endoleaks or migration | Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Number of Major Adverse Events (MAEs) | Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc | >30 Days to 5 Years |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontificia Universidad Católica de Chile | Santiago | Chile | ||||
| Auckland City Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23466185 | Derived | Holden A, Mertens R, Hill A, Marine L, Clair DG. Initial experience with the Ventana fenestrated system for endovascular repair of juxtarenal and pararenal aortic aneurysms. J Vasc Surg. 2013 May;57(5):1235-45. doi: 10.1016/j.jvs.2012.10.125. Epub 2013 Mar 5. |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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All adverse events, whether serious or non-serious
| Procedurally to 5 Years |
| Distal Blood Flow | Ankle-brachial index measurements | Discharge to 5 Years |
| Renal Dysfunction | eGFR reduction >30% from baseline | Discharge to 5 Years |
| Device Performance | Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology | 30 Days to 5 Years |
| Auckland |
| New Zealand |