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This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable.
Primary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Task navigation using fluoroscopy guidance | No Intervention | Standard of care treatment using | |
| Task navigation using LumiGuide | Active Comparator | Standard of care treatment using LumiGuide fluoroscopy guidance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance | Radiation | Fenestrated Endovascular Aortic Repair (FEVAR) procedure done with either LumiGuide or conventional fluoroscopy guidance |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR). | Procedure fluoroscopy time | Fenestrated Endovascular Aortic Repair (FEVAR) procedure (skin to skin procedure time) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bart Wessels | Contact | bart.wessels@philips.com | bart.wessels@philips.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Recruiting | Birmingham | Alabama | 35249 | United States |
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| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| Beth Israel Deaconess Medical Center | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
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| University of Massachusetts | Recruiting | Worcester | Massachusetts | 01655 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| UZ Gent | Recruiting | Ghent | Belgium |
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| Rigshospitalet University Hospital | Not yet recruiting | Copenhagen | Denmark |
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| Hôpital Universitaire Pitié-Salpêtrière | Recruiting | Paris | France |
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| UMC Maastricht | Recruiting | Maastricht | Netherlands |
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| University Medical Center Utrecht | Not yet recruiting | Utrecht | 3508GA | Netherlands |
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| Guys & St Thomas | Recruiting | London | United Kingdom |
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