Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA
NCT ID: NCT02989948
Last Updated: 2025-09-23
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
38 participants
INTERVENTIONAL
2020-04-22
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Main Arm - Physician-modified fenestrated endovascular graft
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.
Physician-modified aortic endograft
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.
Expanded Access Arm - Physician-modified fenestrated endovascular graft.
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.
Physician-modified aortic endograft
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.
Interventions
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Physician-modified aortic endograft
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.
Eligibility Criteria
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Inclusion Criteria
2. Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.
3. Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta).
4. Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.
5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.
6. Must be able to provide informed consent.
7. Must be able to comply with the five year study assessment schedule of events.
8. Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, of greater than 2 years.
1. Must be a man or woman 50 years of age or older by the date of informed consent
2. Must have a thoracic, thoracoabdominal, or abdominal aortic aneurysm that necessitates coverage of one or more visceral vessels (celiac, superior mesenteric, or renals) for establishment of proximal and/or distal seal.
3. Must have an aneurysm size that meets standard size indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta); or, in the judgment of the S-I, has aneurysm characteristics that portend a high risk of near-term rupture
4. Must be considered, in the judgement of the S-I, to be a high risk candidate for open surgical repair
5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft
6. Patient must be able to provide informed consent
7. Must be able to comply with the five year study assessment schedule of events
8. Must have a non-aneurysm-related life expectancy, in the judgement of the S-I, of greater than 2 years
Exclusion Criteria
2. Ruptured or acutely symptomatic aortic aneurysm.
3. Known connective tissue disorder.
4. Imaging demonstrating any of the following:
* Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition).
* Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac).
* Branch vessel target (renal, superior mesenteric, or celiac) \< 5 mm or \> 10 mm in average diameter.
* Untreated left subclavian artery stenosis or occlusion.
* Untreated unilateral or bilateral hypogastric artery occlusion.
* Signs that the inferior mesenteric artery is indispensable.
* Have branching, duplication, aneurysm, or untreatable stenosis of the celiac, superior mesenteric artery, or renal arteries that would preclude implantation of the investigational devices.
5. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold.
6. History of anaphylaxis to contrast, with inability to prophylax appropriately.
7. Have uncorrectable coagulopathy.
8. Have unstable angina.
9. Have a body habitus that would inhibit X-ray visualization of the aorta.
10. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.
11. Known to be participating in any other clinical study which may affect performance of this device.
12. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
13. Contraindication to oral antiplatelet therapy.
14. Prisoners or those on alternative sentencing.
15. Known systemic infection with potential for endovascular graft infection.
16. Anticipated need for MRI scanning within 3 months of insertion of investigational product.
17. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient.
1. Known or suspected mycotic aneurysm
2. Ruptured aneurysm with hemodynamic instability
3. Known connective tissue disorder
4. Imaging demonstrating any of the following:
* Lack of 20 mm non-aneurysmal proximal seal zone (in either native aorta, elephant trunk graft, or aortic arch endograft)
* Lack of 15 mm non-aneurysmal distal seal zone(s) (in either native aortoiliac vessels, prosthetic aortoiliac grafts, or aortoiliac endografts)
* Branch vessel target (renal, superior mesenteric, or celiac) \> 10 mm in average diameter
5. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
6. History of anaphylaxis to contrast, with inability to prophylax appropriately.
7. Have uncorrectable coagulopathy
8. Have a body habitus that would inhibit X-ray visualization of the aorta
9. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
10. Known to be participating in any other clinical study which may affect performance of this device
11. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
12. Contraindication to oral antiplatelet therapy
13. Prisoners or those on alternative sentencing
14. Known systemic infection with potential for endovascular graft infection
15. Anticipated need for MRI scanning within 3 months of insertion of investigational product
16. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient
50 Years
95 Years
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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David Kuwayama
Associate Professor of Surgery
Principal Investigators
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David P. Kuwayama, M.D., M.P.A.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Countries
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References
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Crawford ES, Coselli JS. Thoracoabdominal aneurysm surgery. Semin Thorac Cardiovasc Surg. 1991 Oct;3(4):300-22. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2000035699
Identifier Type: OTHER
Identifier Source: secondary_id
D18194
Identifier Type: -
Identifier Source: org_study_id
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