Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physician-modified endografts | Experimental | For this clinical protocol, endografts which are commercially available will be modified in a sterile fashion on a back-table in the operating room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PMEG | Device | All devices that will be modified in this study protocol are commercially available in the United States. The commercially available endografts will be used to construct a fenestrated/branched device for this intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with 30-day major adverse events from primary procedure | Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation >72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc | Day 30 |
| Number of subjects with treatment success | Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with mortality, major adverse events, spinal cord ischemia | Mortality includes all-cause mortality. Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation >72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc. Spinal cord ischemia data will include all incidence and degree of spinal cord ischemia. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beth Montera | Contact | 8138447948 | bmontera@usf.edu | |
| Konstantinos Arnaoutakis, MD | Contact | arnaoutakis@usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Konstantinos Arnaoutakis, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29224942 | Background | Dossabhoy SS, Simons JP, Flahive JM, Aiello FA, Sheth P, Arous EJ, Messina LM, Schanzer A. Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices. J Vasc Surg. 2018 Jun;67(6):1673-1683. doi: 10.1016/j.jvs.2017.10.055. Epub 2017 Dec 8. | |
| 30583902 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 |
| Number of subjects with treatment success and freedom from secondary intervention | Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality. Freedom from secondary interventions includes interventions to treat malperfusion, rupture, aneurysm formation, aortic expansion, endoleak, device stenosis/occlusion, or access site complication. | Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 |
| University of South Florida - South Tampa Campus | Recruiting | Tampa | Florida | 33606 | United States |
|
| Oderich GS, Ribeiro MS, Sandri GA, Tenorio ER, Hofer JM, Mendes BC, Chini J, Cha S. Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2019 Jul;70(1):31-42.e7. doi: 10.1016/j.jvs.2018.09.063. Epub 2018 Dec 21. |
| 26792544 | Background | Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Apr;63(4):930-42. doi: 10.1016/j.jvs.2015.10.095. Epub 2016 Jan 11. |
| 28259577 | Background | Schanzer A, Simons JP, Flahive J, Durgin J, Aiello FA, Doucet D, Steppacher R, Messina LM. Outcomes of fenestrated and branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2017 Sep;66(3):687-694. doi: 10.1016/j.jvs.2016.12.111. Epub 2017 Mar 1. |
| 27986479 | Background | Oderich GS, Ribeiro M, Hofer J, Wigham J, Cha S, Chini J, Macedo TA, Gloviczki P. Prospective, nonrandomized study to evaluate endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts based on supraceliac sealing zones. J Vasc Surg. 2017 May;65(5):1249-1259.e10. doi: 10.1016/j.jvs.2016.09.038. Epub 2016 Dec 13. |
| 17257941 | Background | Conrad MF, Crawford RS, Davison JK, Cambria RP. Thoracoabdominal aneurysm repair: a 20-year perspective. Ann Thorac Surg. 2007 Feb;83(2):S856-61; discussion S890-2. doi: 10.1016/j.athoracsur.2006.10.096. |
| 17257942 | Background | Coselli JS, Bozinovski J, LeMaire SA. Open surgical repair of 2286 thoracoabdominal aortic aneurysms. Ann Thorac Surg. 2007 Feb;83(2):S862-4; discussion S890-2. doi: 10.1016/j.athoracsur.2006.10.088. |
| 19362499 | Background | Schepens MA, Heijmen RH, Ranschaert W, Sonker U, Morshuis WJ. Thoracoabdominal aortic aneurysm repair: results of conventional open surgery. Eur J Vasc Endovasc Surg. 2009 Jun;37(6):640-5. doi: 10.1016/j.ejvs.2009.03.011. Epub 2009 Apr 11. |
| 31727462 | Background | Arnaoutakis DJ, Scali ST, Beck AW, Kubilis P, Huber TS, Martin AJ, Laquian L, Back M, Giles KA, Fatima J, Beaver TM, Upchurch GR Jr. Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 May;71(5):1503-1514. doi: 10.1016/j.jvs.2019.08.236. Epub 2019 Nov 11. |
| 29017806 | Background | Scali ST, Kim M, Kubilis P, Feezor RJ, Giles KA, Miller B, Fatima J, Huber TS, Berceli SA, Back M, Beck AW. Implementation of a bundled protocol significantly reduces risk of spinal cord ischemia after branched or fenestrated endovascular aortic repair. J Vasc Surg. 2018 Feb;67(2):409-423.e4. doi: 10.1016/j.jvs.2017.05.136. Epub 2017 Oct 7. |
| 37451371 | Derived | Asirwatham M, Konanki V, Lucas SJ, Grundy S, Zwiebel B, Shames M, Arnaoutakis DJ. Comparative outcomes of physician-modified fenestrated/branched endovascular aortic aneurysm repair in the setting of prior failed endovascular aneurysm repair. J Vasc Surg. 2023 Nov;78(5):1153-1161. doi: 10.1016/j.jvs.2023.07.002. Epub 2023 Jul 13. |
| D002318 |
| Cardiovascular Diseases |
| D001018 | Aortic Diseases |