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| Name | Class |
|---|---|
| Cook Group Incorporated | INDUSTRY |
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This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch pathologies involving the at least one brachiocephalic artery or visceral vessels.
The three investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.
Described as follows: Juxtarenal, Suprarenal, Thoracoabdominal aortic pathologies involving at least one visceral artery. Aortic Arch pathologies involving the at least one brachiocephalic artery.
Once the participant has signed the approved informed consent the following tests will be done to determine final subject eligibility and which device will be used:
Juxtarenal, Suprarenal, Thoracoabdominal: Clinical Exam, Blood Tests, CT Scans (with and without contrast), Abdominal Device X-ray, and Angiography.
Aortic Arch: Clinical Exam, Neurological Exam, Blood Tests, Echocardiogram, CT Scans (with and without contrast), Chest X-ray, and Angiography.
The participants will be followed for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cook Custom Aortic Endograft | Experimental | Participants will receive the following: (Juxtarenal, Suprarenal, Thoracoabdominal) Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. (Aortic Arch) Clinical Exam, Neurological Exam, Blood Tests, Echocardiogram, CT Scans (with and without contrast), Chest X-ray, and Angiography. These tests will aid in the design of the Cook Custom Aortic Endograft. The Cook Custom Aortic Endograft has a variable design such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal aorta, thoracoabdominal aorta, or the aortic arch aorta. Grafts may include a combination of up to 5 fenestrations and/or branches. |
|
| Zenith t-Branch Endovascular Graft | Experimental | Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the sizing of the the Zenith t-Branch Endovascular Graft. The Zenith t-Branch Endovascular Graft is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for proximal fixation of the device. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents. |
|
| Surgeon-Modified Endograft | Experimental | Participants will receive the following: Clinical Exam, Blood Tests, CT Scans (with and without contrast) or Ultrasound, Abdominal Device X-ray, and Angiography. These tests will aid in the design of the Surgeon-Modified Endografts. These will be created in the operating room by modifying a commercially-available Cook Alpha Thoracic Endograft or Cook Zenith Infrarenal Aortic Device such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook Custom Aortic Endograft | Device | The Cook Custom Aortic Endograft has a variable design such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal aorta, thoracoabdominal aorta, or the aortic arch aorta. Grafts may include a combination of up to 5 fenestrations and/or branches. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of major adverse events at 30 days post primary procedure | 30 days post primary procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all-cause mortality in peri-operative period | Peri-operative | |
| Rate of all-cause mortality at 30 days post primary procedure | 30 days post primary procedure | |
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Inclusion Criteria:
Juxtarenal, suprarenal, and thoracoabdominal aortic pathology as follows in hemodynamically stable patients:
Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic/degenerative or saccular) involving or in close approximation to the visceral segment of the aorta.
Penetrating aortic ulcer (PAU)
Subacute (>14 days) or chronic (>20 days) aortic dissection with aneurysmal degeneration with at least one of the following:
Aortic Arch pathology:
Aneurysm, Ascending thoracic aortic pseudoaneurysm, Type A thoracic aortic dissection, Retrograde type A thoracic aortic dissection between the Sinus of Valsalva and the innominate artery orifice (without involvement of the Aortic Valve), or Ascending penetrating aortic ulcer with and without intramural hematoma
Suitable iliac artery and brachial artery access
Absence of severe landing zone (> 90 degree) angulation that would preclude necessary device delivery/seal/fixation.
Suitable iliac artery access to accommodate device delivery system.
Target arteries for arch branches:
Aortic Arch Aneurysm
Proximal aortic fixation zone:
Proximal neck length > 20 mm
Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion.
Distal aortic fixation zone:
Distal neck length > 20 mm. However, if dissection, distal graft may land in dissected aorta.
Supra-aortic trunk (brachiocephalic) vessels (Any combination of arteries may be used for repair) A. Innominate artery
Aortic Dissection
General Exclusion Criteria:
Medical Exclusion Criteria:
Anatomical Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam W Beck, MD | Contact | awbeck@uabmc.edu | ||
| Rebecca St John | Contact | rstjohn@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Adam W Beck, MD | University of Alabama at Bimingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39963789 | Derived | Mesnard T, Huang Y, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Zetterval SL, Lee A, Oderich GS; United States Aortic Research Consortium. Multicenter Prospective Evaluation of Patient Radiation Exposure During Fenestrated-branched Endovascular Aortic Repair: A Ten-year Experience. Ann Surg. 2026 Jul 1;284(1):184-193. doi: 10.1097/SLA.0000000000006676. Epub 2025 Feb 18. | |
| 38989575 |
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|
| Zenith t-Branch Endovascular Graft | Device | The Zenith t-Branch Endovascular Graft is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for proximal fixation of the device. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents. |
|
| Surgeon-Modified Endograft | Device | The Surgeon-Modified Endografts are created in the operating room by modifying a commercially-available Cook Alpha Thoracic Endograft or Cook Zenith Infrarenal Aortic Device such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches. |
|
| Number of major adverse events at 6 months post primary procedure |
| 6 months post primary procedure |
| Number of subjects requiring ventilation more than 48 hours in peri-operative period | Peri-operative |
| Average length of ventilation past 48 hours in peri-operative period | Peri-operative |
| Number of subjects requiring reintubation in peri-operative period | Peri-operative |
| Average ICU length of stay in peri-operative period | Peri-operative |
| Number of patients who underwent tracheostomy to treat pulmonary failure at 30 days post primary procedure | 30 days post primary procedure |
| Number of patients who developed postoperative pneumonia at 30 days post primary procedure | 30 days post primary procedure |
| Number of patent treated branch vessels at 30 days post primary procedure | 30 days post primary procedure |
| Number of patients with loss of device integrity at 30 days post primary procedure | 30 days post primary procedure |
| Freedom from reintervention at 30 days post primary procedure | 30 days post primary procedure |
| Number of subjects that achieve treatment success at 12 months post procedure | Treatment success is defined as procedural technical success and patent treated branch vessels at 12 months post procedure, device integrity, and freedom from both reintervention and aortic enlargement ≤5mm as compared to baseline at 12 months post primary procedure. Technical success is defined as successful exclusion of the diseased aortic segment without a clinically significant type I or type III endoleak and patent treated branch vessels at the end of the procedure without the need for unanticipated corrective interventions. | 12 months post procedure |
| Number of major adverse events at 12 months post procedure | 12 months post primary procedure |
| Number of major adverse events at 2 years post primary procedure | 2 years post primary procedure |
| Number of major adverse events at 3 years post primary procedure | 3 years post primary procedure |
| Number of major adverse events at 4 years post primary procedure | 4 years post primary procedure |
| Number of major adverse events at 5 years post primary procedure | 5 years post primary procedure |
| Number of patients who underwent tracheostomy to treat pulmonary failure at 6 months post primary procedure | 6 months post primary procedure |
| Number of patients who underwent tracheostomy to treat pulmonary failure at 12 months post primary procedure | 12 months post primary procedure |
| Number of patients who developed postoperative pneumonia at 6 months post primary procedure | 6 months post primary procedure |
| Number of patients who developed postoperative pneumonia at 12 months post primary procedure | 12 months post primary procedure |
| Number of patent treated branch vessels at 6 months post primary procedure | 6 months post primary procedure |
| Number of patent treated branch vessels at 12 months post primary procedure | 12 months post primary procedure |
| Number of patent treated branch vessels at 2 years post primary procedure | 2 years post primary procedure |
| Number of patent treated branch vessels at 3 years post primary procedure | 3 years post primary procedure |
| Number of patent treated branch vessels at 4 years post primary procedure | 4 years post primary procedure |
| Number of patent treated branch vessels at 5 years post primary procedure | 5 years post primary procedure |
| Number of patients with loss of device integrity at 6 months post primary procedure | 6 months post primary procedure |
| Number of patients with loss of device integrity at 12 months post primary procedure | 12 months post primary procedure |
| Number of patients with loss of device integrity at 2 years post primary procedure | 2 years post primary procedure |
| Number of patients with loss of device integrity at 3 years post primary procedure | 3 years post primary procedure |
| Number of patients with loss of device integrity at 4 years post procedure | 4 years post procedure |
| Number of patients with loss of device integrity at 5 years post primary procedure | 5 years post primary procedure |
| Freedom from reintervention at 6 months post primary procedure | 6 months post primary procedure |
| Freedom from reintervention at 12 months post primary procedure | 12 months post primary procedure |
| Freedom from reintervention at 2 years post primary procedure | 2 years post primary procedure |
| Freedom from reintervention at 3 years post primary procedure | 3 years post primary procedure |
| Freedom from reintervention at 4 years post primary procedure | 4 years post primary procedure |
| Freedom from reintervention at 5 years post primary procedure | 5 years post primary procedure |
| Number of major adverse events at 30 days post primary procedure | 30 days post primary procedure |
| Rate of neurologic morbidity in peri-operative period | Peri-operative |
| Rate of neurologic morbidity at hospital discharge | Peri-operative |
| Rate of neurologic morbidity at 30 days post primary procedure | 30 days post primary procedure |
| Rate of neurologic morbidity at 6 months post primary procedure | 6 months post primary procedure |
| Rate of neurologic morbidity at 12 months post primary procedure | 12 months post primary procedure |
| Rate of neurologic morbidity at 1 year post primary procedure | 1 year post primary procedure |
| Rate of neurologic morbidity at 2 year post primary procedure | 2 year post primary procedure |
| Rate of neurologic morbidity at 3 year post primary procedure | 3 year post primary procedure |
| Rate of neurologic morbidity at 4 year post primary procedure | 4 year post primary procedure |
| Rate of neurologic morbidity at 5 year post primary procedure | 5 year post primary procedure |
| Derived |
| Oderich GS, Huang Y, Harmsen WS, Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Gasper WJ, Beck AW, Sweet MP, Lee WA; United States Aortic Research Consortium. Early and Late Aortic-Related Mortality and Rupture After Fenestrated-Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysms: A Prospective Multicenter Cohort Study. Circulation. 2024 Oct 22;150(17):1343-1353. doi: 10.1161/CIRCULATIONAHA.123.068234. Epub 2024 Jul 11. |
| 37330702 | Derived | Finnesgard EJ, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Simons JP, Schanzer A; United States Aortic Research Consortium. Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair. J Vasc Surg. 2023 Oct;78(4):892-901. doi: 10.1016/j.jvs.2023.05.034. Epub 2023 Jun 16. |
| 37059239 | Derived | Aucoin VJ, Motyl CM, Novak Z, Eagleton MJ, Farber MA, Gasper W, Oderich GS, Mendes B, Schanzer A, Tenorio E, Timaran CH, Schneider DB, Sweet MP, Zettervall SL, Beck AW; U.S. Aortic Research Consortium. Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium. J Vasc Surg. 2023 Jun;77(6):1578-1587. doi: 10.1016/j.jvs.2023.01.205. Epub 2023 Apr 13. |
| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| D000094667 | Penetrating Atherosclerotic Ulcer |
| D000094626 | Aneurysm, Aortic Arch |
| D000784 | Aortic Dissection |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D017545 | Aortic Aneurysm, Thoracic |
| D000094665 | Dissection, Blood Vessel |
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