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Aortic Aneurysm, ThoracoabdominalNCT02989948

Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA

A study testing Physician-modified aortic endograft in people with Aortic Aneurysm, Thoracoabdominal, run by Yale University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 95 years
Conditions the study is for
Aortic Aneurysm, Thoracoabdominal
What is being tested?
Physician-modified aortic endograft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesUnited States
Study dates
22 Apr 2020to 31 Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

MAIN ARM - Inclusion Criteria:

  1. Must be a man or woman 50 years of age or older by the date of informed consent.
  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.

MAIN ARM - Exclusion Criteria:

  1. Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection.
  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.
  1. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold.
  2. History of anaphylaxis to contrast, with inability to prophylax appropriately.
  3. Have uncorrectable coagulopathy.
  4. Have unstable angina.
  5. Have a body habitus that would inhibit X-ray visualization of the aorta.
  6. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.
  7. Known to be participating in any other clinical study which may affect performance of this device.
  8. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
  9. Contraindication to oral antiplatelet therapy.
  10. Prisoners or those on alternative sentencing.
  11. Known systemic infection with potential for endovascular graft infection.
  12. Anticipated need for MRI scanning within 3 months of insertion of investigational product.
  13. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient.

EXPANDED ACCESS ARM - Inclusion Criteria

  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

EXPANDED ACCESS ARM - Exclusion Criteria

  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
  1. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
  2. History of anaphylaxis to contrast, with inability to prophylax appropriately.
  3. Have uncorrectable coagulopathy
  4. Have a body habitus that would inhibit X-ray visualization of the aorta
  5. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
  6. Known to be participating in any other clinical study which may affect performance of this device
  7. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
  8. Contraindication to oral antiplatelet therapy
  9. Prisoners or those on alternative sentencing
  10. Known systemic infection with potential for endovascular graft infection
  11. Anticipated need for MRI scanning within 3 months of insertion of investigational product
  12. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

David P. Kuwayama, M.D., MPA contact

David.kuwayama@yale.edu

United States2 sites, 1 recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Active, not recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

    David Kuwayama, M.D, MPA, (203) 785-2561, David.kuwayama@yale.edu

    David Kuwayama, M.D., MPA

    Recruiting

Other trials in United States

About this study

Official title: Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms (TAAA)

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.

Read the detailed description

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.

Being tested
Physician-modified aortic endograft
Keywords
endovascular, physician-modified, graft, fenestration
Medical subject headings
Aortic Aneurysm, Thoracoabdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physician-modified aortic endograftDevice

    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.

Study groups in NCT02989948
Study groupRoleWhat they receive
Main Arm - Physician-modified fenestrated endovascular graftExperimentalUse 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.
Receives: Device: Physician-modified aortic endograft
Expanded Selection Criteria Arm - Physician-modified fenestrated endovascular graft.ExperimentalUse 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.
Receives: Device: Physician-modified aortic endograft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30 day survival

    Percent of patients who survive 30 days following surgery

    Measured: 30 Days

  2. Major Adverse Events (MAE) at 30 days following surgery

    Percent of patients who development major adverse events

    Measured: 30 Days

  3. Treatment success at 12 months following surgery

    Percent of patients achieving treatment success through 1 year

    Measured: 12 Months

  4. 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.

    Measured: 12 Months

Secondary outcomes (13)

  1. 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.

    Measured: Day of Surgery

  2. Aneurysm rupture

    Percent of patients developing aneurysm rupture

    Measured: Day of Surgery

  3. 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.

    Measured: Day of Surgery

  4. 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.

    Measured: Day of Surgery

  5. 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.

    Measured: Day of Surgery

  6. 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.

    Measured: Day of Surgery

  7. 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.

    Measured: Day of Surgery

  8. 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.

    Measured: Day of Surgery

  9. 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.

    Measured: Day of Surgery

  10. Death during surgery

    Percent of patients who die during surgery

    Measured: Day of Surgery

  11. Survival rate

    Percent of patients who survive

    Measured: At 30, 183 days; 1, 2, 3, 4 and 5 years

  12. Major Adverse Events (MAEs)

    Percent of patients that development MAEs

    Measured: At 30, 183 days; 1, 2, 3, 4 and 5 years

  13. Treatment success

    Percent of patients achieving treatment success

    Measured: At 30, 183 days; 2, 3, 4 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2016 (estimated)
  2. Study start22 Apr 2020
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02989948
Sponsor's protocol ID
D18194
Other IDs
2000035699
Status last verified
Aug 2026
First submitted
5 Dec 2016
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No plan to share individual participant data (IPD) exists at this time.

Publications

  • Crawford ES, Coselli JS. Thoracoabdominal aneurysm surgery. Semin Thorac Cardiovasc Surg. 1991 Oct;3(4):300-22. No abstract available.

    PubMed 1793767

  • 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.

    PubMed 10391343

  • 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.

    PubMed 8176976

  • 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.

    PubMed 22840907

  • 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.

    PubMed 9851478

  • 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.

    PubMed 17182917

  • 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.

    PubMed 25449006

  • 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.

    PubMed 24785682

  • 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.

    PubMed 21092788

  • 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.

    PubMed 18678769

  • 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.

    PubMed 24636714

  • 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.

    PubMed 21502107

  • 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.

    PubMed 21810808

  • 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.

    PubMed 22205654

  • 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.

    PubMed 22205653

Questions about this trial

What is this clinical trial studying?

A study testing Physician-modified aortic endograft in people with Aortic Aneurysm, Thoracoabdominal, run by Yale University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David P. Kuwayama, M.D., MPA (David.kuwayama@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30 day survival (time frame: 30 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02989948, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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