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Endologix Infrarenal Bifurcated Stent Graft Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Repair - EVAR (Powerlink System) | Experimental | EVAR (Powerlink System) |
|
| Open Surgical Control | Active Comparator | Open Surgical Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Powerlink infrarenal bifurcated stent graft delivery system | Device | Endovascular abdominal aortic aneurysm repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| No of Subjects with Major adverse events | Aneurysm-related mortality, aneurysm rupture, conversion to open repair, coronary intervention, myocardial infarction, renal failure, respiratory failure, secondary procedure, and stroke | At 1 Year |
| All Cause Mortality | No of deaths reported through 1 year | At 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | 30 Days |
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodney White, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Institute | Phoenix | Arizona | 85006 | United States | ||
| Harbor-UCLA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16760859 | Result | Carpenter JP. The Powerlink bifurcated system for endovascular aortic aneurysm repair: four-year results of the US multicenter trial. J Cardiovasc Surg (Torino). 2006 Jun;47(3):239-43. | |
| 16414382 | Result | Parmer SS, Carpenter JP; Endologix Investigators. Endovascular aneurysm repair with suprarenal vs infrarenal fixation: a study of renal effects. J Vasc Surg. 2006 Jan;43(1):19-25. doi: 10.1016/j.jvs.2005.09.025. |
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| Open Surgery | Procedure | Open surgical abdominal aortic aneurysm repair |
|
| 6 Months |
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | Year 1 |
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | Year 2 |
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | Year 3 |
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | Year 4 |
| Stent Graft Performance | Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration | Year 5 |
| Clinical Utility Outcomes | Estimated anesthesia time, fluoroscopy time, procedure time | During the Procedure |
| Clinical Utility Outcomes | Estimated blood loss (ml) and contrast volume (ml). Estimated blood loss records the approximate amount of blood that the patient lost during the surgery (ml) and contract volume is the volume of the contrast (ml) calculated during the procedure. | During the Procedure |
| Clinical Utility Outcomes | Estimated ICU time | up to 1 week |
| Clinical Utility Outcomes | Estimated Hospitalization Time | up to 1 week |
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to 6 Months | 6 Months |
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 1 | Year 1 |
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 2 | Year 2 |
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 3 | Year 3 |
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 4 | Year 4 |
| Aneurysm Morphology | Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 5 | Year 5 |
| Torrance |
| California |
| 90506 |
| United States |
| University of Illinois School of Medicine | Peoria | Illinois | 61604 | United States |
| SIU School of Medicine | Springfield | Illinois | 62702 | United States |
| Mercy Hospital | Des Moines | Iowa | 50314 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Advanced Vascular Associates | Morristown | New Jersey | 07960 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oklahoma Cardiovascular Research Group | Oklahoma City | Oklahoma | 73120 | United States |
| University Hospital of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Heart Hospital of South Dakota | Sioux Falls | South Dakota | 57108 | United States |
| Vascular and Transplant Specialists | Norfolk | Virginia | 23510 | United States |
| 19088132 | Result | Wang GJ, Carpenter JP. EVAR in small versus large aneurysms: does size influence outcome? Vasc Endovascular Surg. 2009 Jun-Jul;43(3):244-51. doi: 10.1177/1538574408327570. Epub 2008 Dec 16. |
| 18635335 | Result | Wang GJ, Carpenter JP; Endologix Investigators. The Powerlink system for endovascular abdominal aortic aneurysm repair: six-year results. J Vasc Surg. 2008 Sep;48(3):535-45. doi: 10.1016/j.jvs.2008.04.031. Epub 2008 Jul 16. |
| 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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| ID | Term |
|---|---|
| D061887 | Conversion to Open Surgery |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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