Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA

NCT02989948 | Recruiting DMC FDA Device

• 2 other identifiers: D181942000035699
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Aortic Aneurysm, Thoracoabdominal

Keywords

endovascular; physician-modified; graft; fenestration

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (13)

• Technical success on the day of surgery

  Day of Surgery

• Aneurysm rupture

  Day of Surgery

• Conversion to open repair

  Day of Surgery

• Access site complication (Femoral or Iliac)

  Day of Surgery

• Lower extremity ischemia

  Day of Surgery

Study Arms (2)

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.

Device: Physician-modified aortic endograft

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.

Device: Physician-modified aortic endograft

Interventions

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.

Expanded Access Arm - Physician-modified fenestrated endovascular graft.; Main Arm - Physician-modified fenestrated endovascular graft

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a man or woman 50 years of age or older by the date of informed consent.
• Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.
• 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).
• Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.
• Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.
• Must be able to provide informed consent.
• Must be able to comply with the five year study assessment schedule of events.
• Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, of greater than 2 years.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

ACTIVE NOT RECRUITING

Related Publications (19)

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  PMID: 1793767 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.

  PMID: 10391343 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.

  PMID: 8176976 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.

  PMID: 22840907 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.

  PMID: 9851478 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.

  PMID: 17182917 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.

  PMID: 25449006 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.

  PMID: 24785682 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.

  PMID: 21092788 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.

  PMID: 18678769 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.

  PMID: 24636714 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.

  PMID: 21502107 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.

  PMID: 21810808 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.

  PMID: 22205654 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.

  PMID: 22205653 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.

  PMID: 21810817 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.

  PMID: 10610834 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.

  PMID: 19945316 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.

  PMID: 22554425 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• David P. Kuwayama, M.D., M.P.A.

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David P. Kuwayama, M.D., MPA

CONTACT

David.kuwayama@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 12, 2016
• Study Start: April 22, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)