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| ID | Type | Description | Link |
|---|---|---|---|
| 2000035699 | Other Identifier | Yale IRB |
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The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.
This study is a prospective, two-arm, traditional feasibility study of a physician modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft base device in adult patients meeting traditional size criteria for open surgical treatment of thoracoabdominal aortic aneurysms (TAAAs). Patients meriting surgical treatment of their aneurysm that also meet inclusion and exclusion criteria will be eligible for enrollment. Patients will be followed for 5 years post procedure. Major adverse events (MAEs) will also be recorded by the Sponsor-Investigator (S-I) and will be monitored by a locally appointed Data Monitoring Committee, Dartmouth-Hitchcock Health and the D-HH Human Research Protection Program IRB/IEC, and the FDA. This record was transferred to Yale in October 2024.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Arm - Physician-modified fenestrated endovascular graft | Experimental | Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair. |
|
| Expanded Access Arm - Physician-modified fenestrated endovascular graft. | Experimental | Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal, thoracic, or abdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair in an expanded use population. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physician-modified aortic endograft | Device | Use of physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair. |
| Measure | Description | Time Frame |
|---|---|---|
| 30 day survival | Percent of patients who survive 30 days following surgery | 30 Days |
| Major Adverse Events (MAE) at 30 days following surgery | Percent of patients who development major adverse events | 30 Days |
| Treatment success at 12 months following surgery | Percent of patients achieving treatment success through 1 year | 12 Months |
| Technical success at 12 months following surgery | Technical success is assessed 12 months following surgery and is defined as a composite of: successful delivery, without need for unanticipated corrective intervention related to delivery; successful and accurate deployment at the intended implantation site; and successful withdrawal, without need for unanticipated correct intervention related to withdrawal. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success on the day of surgery | Percent of patients achieving technical success on the day of surgery, defined as the composite of; successful delivery, successful and accurate deployment, successful withdrawal. | Day of Surgery |
| Aneurysm rupture |
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MAIN ARM - Inclusion Criteria:
MAIN ARM - Exclusion Criteria:
Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection.
Ruptured or acutely symptomatic aortic aneurysm.
Known connective tissue disorder.
Imaging demonstrating any of the following:
Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold.
History of anaphylaxis to contrast, with inability to prophylax appropriately.
Have uncorrectable coagulopathy.
Have unstable angina.
Have a body habitus that would inhibit X-ray visualization of the aorta.
Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.
Known to be participating in any other clinical study which may affect performance of this device.
Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
Contraindication to oral antiplatelet therapy.
Prisoners or those on alternative sentencing.
Known systemic infection with potential for endovascular graft infection.
Anticipated need for MRI scanning within 3 months of insertion of investigational product.
Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient.
EXPANDED ACCESS ARM - Inclusion Criteria
EXPANDED ACCESS ARM - Exclusion Criteria
Known or suspected mycotic aneurysm
Ruptured aneurysm with hemodynamic instability
Known connective tissue disorder
Imaging demonstrating any of the following:
Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
History of anaphylaxis to contrast, with inability to prophylax appropriately.
Have uncorrectable coagulopathy
Have a body habitus that would inhibit X-ray visualization of the aorta
Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
Known to be participating in any other clinical study which may affect performance of this device
Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
Contraindication to oral antiplatelet therapy
Prisoners or those on alternative sentencing
Known systemic infection with potential for endovascular graft infection
Anticipated need for MRI scanning within 3 months of insertion of investigational product
Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David P. Kuwayama, M.D., MPA | Contact | David.kuwayama@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| David P. Kuwayama, M.D., M.P.A. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1793767 | Background | Crawford ES, Coselli JS. Thoracoabdominal aneurysm surgery. Semin Thorac Cardiovasc Surg. 1991 Oct;3(4):300-22. No abstract available. | |
| 10391343 | Background | Safi HJ, Miller CC 3rd. Spinal cord protection in descending thoracic and thoracoabdominal aortic repair. Ann Thorac Surg. 1999 Jun;67(6):1937-9; discussion 1953-8. doi: 10.1016/s0003-4975(99)00397-5. |
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No plan to share individual participant data (IPD) exists at this time.
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| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
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|
Percent of patients developing aneurysm rupture |
| Day of Surgery |
| Conversion to open repair | Percent of patients necessitating conversion to open repair. This is assessed intraoperatively. In case of a device deployment failure or intraoperative aneurysm rupture, emergent conversion to open repair via laparotomy, thoracotomy, or thoracoabdominal aortic exposure may become necessary. Patients undergoing such intraoperative conversion will be considered to have met this endpoint. | Day of Surgery |
| Access site complication (Femoral or Iliac) | Percent of patients suffering access site complication (femoral or iliac). If femoral or iliac rupture occurs intraoperatively, or if femoral or iliac flow-limiting dissection or occlusion is identified intraoperatively or on the day of surgery, patients will be considered to have met this outcome. | Day of Surgery |
| Lower extremity ischemia | Percent of patients developing lower extremity ischemia. This will be assess intraoperatively and on the day of surgery. If patients have lower extremity pulses either absent or diminished compared to baseline, with associated pain, sensory deficits or motor deficits on clinical evaluation, patients will be considered to have met this outcome. | Day of Surgery |
| Lower extremity compartment syndrome | Percent of patients developing lower extremity compartment syndrome. In patients with lower extremity pain to passive motion post-operatively, invasive pressure measurement of the four calf compartments will be performed. If compartment pressures are greater than 30 in any compartment, patients will be considered to have met this outcome. | Day of Surgery |
| Stroke | Percent of patients developing stroke - Modified Rankin Score (MRS) of 2 or greater). In patients with altered mental status or lateralizing motor or sensory deficits, MRI of the brain will be performed. If diffusion weighted MRI imaging demonstrates an intracranial lesion, a modified Rankin score will be calculated. If MRS is 2 or greater, patients will be considered to have met this outcome. | Day of Surgery |
| Paraplegia | Percent of patients developing paraplegia. Patients with complete absence of lower extremity motor function in one or both legs will be considered to have met this outcome. | Day of Surgery |
| Paraparesis | Percent of patients developing paraparesis. Patients will undergo lower extremity motor strength assessment post-operatively on a standard 0 to 5 scale. If greater than 0 but less than 5 in either extremity, patients will be considered to have met this outcome. | Day of Surgery |
| Death during surgery | Percent of patients who die during surgery | Day of Surgery |
| Survival rate | Percent of patients who survive | At 30, 183 days; 1, 2, 3, 4 and 5 years |
| Major Adverse Events (MAEs) | Percent of patients that development MAEs | At 30, 183 days; 1, 2, 3, 4 and 5 years |
| Treatment success | Percent of patients achieving treatment success | At 30, 183 days; 2, 3, 4 and 5 years |
| Dartmouth-Hitchcock Medical Center | Active, not recruiting | Lebanon | New Hampshire | 03766 | United States |
| 8176976 | Background | Dapunt OE, Galla JD, Sadeghi AM, Lansman SL, Mezrow CK, de Asla RA, Quintana C, Wallenstein S, Ergin AM, Griepp RB. The natural history of thoracic aortic aneurysms. J Thorac Cardiovasc Surg. 1994 May;107(5):1323-32; discussion 1332-3. |
| 22840907 | Background | Kuzmik GA, Sang AX, Elefteriades JA. Natural history of thoracic aortic aneurysms. J Vasc Surg. 2012 Aug;56(2):565-71. doi: 10.1016/j.jvs.2012.04.053. |
| 9851478 | Background | Clouse WD, Hallett JW Jr, Schaff HV, Gayari MM, Ilstrup DM, Melton LJ 3rd. Improved prognosis of thoracic aortic aneurysms: a population-based study. JAMA. 1998 Dec 9;280(22):1926-9. doi: 10.1001/jama.280.22.1926. |
| 17182917 | Background | Cowan JA Jr, Dimick JB, Henke PK, Rectenwald J, Stanley JC, Upchurch GR Jr. Epidemiology of aortic aneurysm repair in the United States from 1993 to 2003. Ann N Y Acad Sci. 2006 Nov;1085:1-10. doi: 10.1196/annals.1383.030. |
| 25449006 | Background | O'Callaghan A, Mastracci TM, Eagleton MJ. Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia. J Vasc Surg. 2015 Feb;61(2):347-354.e1. doi: 10.1016/j.jvs.2014.09.011. Epub 2014 Oct 23. |
| 24785682 | Background | Lee JT, Lee GK, Chandra V, Dalman RL. Comparison of fenestrated endografts and the snorkel/chimney technique. J Vasc Surg. 2014 Oct;60(4):849-56; discussion 856-7. doi: 10.1016/j.jvs.2014.03.255. Epub 2014 Apr 27. |
| 21092788 | Background | Greenberg R, Eagleton M, Mastracci T. Branched endografts for thoracoabdominal aneurysms. J Thorac Cardiovasc Surg. 2010 Dec;140(6 Suppl):S171-8. doi: 10.1016/j.jtcvs.2010.07.061. |
| 18678769 | Background | Greenberg RK, Lu Q, Roselli EE, Svensson LG, Moon MC, Hernandez AV, Dowdall J, Cury M, Francis C, Pfaff K, Clair DG, Ouriel K, Lytle BW. Contemporary analysis of descending thoracic and thoracoabdominal aneurysm repair: a comparison of endovascular and open techniques. Circulation. 2008 Aug 19;118(8):808-17. doi: 10.1161/CIRCULATIONAHA.108.769695. Epub 2008 Aug 4. |
| 24636714 | Background | Matsumura JS, Melissano G, Cambria RP, Dake MD, Mehta S, Svensson LG, Moore RD; Zenith TX2 Clinical Trial Investigators. Five-year results of thoracic endovascular aortic repair with the Zenith TX2. J Vasc Surg. 2014 Jul;60(1):1-10. doi: 10.1016/j.jvs.2014.01.043. Epub 2014 Mar 14. |
| 21502107 | Background | Riga CV, McWilliams RG, Cheshire NJ. In situ fenestrations for the aortic arch and visceral segment: advances and challenges. Perspect Vasc Surg Endovasc Ther. 2011 Sep;23(3):161-5. doi: 10.1177/1531003510388421. Epub 2011 Apr 17. |
| 21810808 | Background | Oderich GS, Greenberg RK. Endovascular iliac branch devices for iliac aneurysms. Perspect Vasc Surg Endovasc Ther. 2011 Sep;23(3):166-72. doi: 10.1177/1531003511408344. Epub 2011 Aug 1. |
| 22205654 | Background | Chuter T, Greenberg RK. Standardized off-the-shelf components for multibranched endovascular repair of thoracoabdominal aortic aneurysms. Perspect Vasc Surg Endovasc Ther. 2011 Sep;23(3):195-201. doi: 10.1177/1531003511430397. |
| 22205653 | Background | Oderich GS, Greenberg RK. The evolving options for endovascular repair of complex aortic aneurysms. Foreword. Perspect Vasc Surg Endovasc Ther. 2011 Sep;23(3):145-8. doi: 10.1177/1531003511407343. No abstract available. |
| 21810817 | Background | O'Brien N, Sobocinski J, d'Elia P, Guillou M, Maioli F, Azzaoui R, Haulon S. Fenestrated endovascular repair of type IV thoracoabdominal aneurysms: device design and implantation technique. Perspect Vasc Surg Endovasc Ther. 2011 Sep;23(3):173-7. doi: 10.1177/1531003511408340. Epub 2011 Aug 1. |
| 10610834 | Background | Browne TF, Hartley D, Purchas S, Rosenberg M, Van Schie G, Lawrence-Brown M. A fenestrated covered suprarenal aortic stent. Eur J Vasc Endovasc Surg. 1999 Nov;18(5):445-9. doi: 10.1053/ejvs.1999.0924. |
| 19945316 | Background | Haulon S, D'Elia P, O'Brien N, Sobocinski J, Perrot C, Lerussi G, Koussa M, Azzaoui R. Endovascular repair of thoracoabdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 2010 Feb;39(2):171-8. doi: 10.1016/j.ejvs.2009.11.009. Epub 2009 Nov 27. |
| 22554425 | Background | Starnes BW. Physician-modified endovascular grafts for the treatment of elective, symptomatic, or ruptured juxtarenal aortic aneurysms. J Vasc Surg. 2012 Sep;56(3):601-7. doi: 10.1016/j.jvs.2012.02.011. Epub 2012 May 2. |
| D002318 |
| Cardiovascular Diseases |
| D001018 | Aortic Diseases |