Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA

Official title

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

Overview

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.

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.

Interventions

• Device 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.

Primary outcome measures

• 30 day survival [Time frame: 30 Days]
• Major Adverse Events (MAE) at 30 days following surgery [Time frame: 30 Days]
• Treatment success at 12 months following surgery [Time frame: 12 Months]
• Technical success at 12 months following surgery [Time frame: 12 Months]

Secondary outcome measures (12)

• Technical success on the day of surgery [Time frame: Day of Surgery]
• Aneurysm rupture [Time frame: Day of Surgery]
• Conversion to open repair [Time frame: Day of Surgery]
• Access site complication (Femoral or Iliac) [Time frame: Day of Surgery]
• Lower extremity ischemia [Time frame: Day of Surgery]
• Lower extremity compartment syndrome [Time frame: Day of Surgery]
• Stroke [Time frame: Day of Surgery]
• Paraplegia [Time frame: Day of Surgery]
• Paraparesis [Time frame: Day of Surgery]
• Death during surgery [Time frame: Day of Surgery]
• Survival rate [Time frame: At 30, 183 days; 1, 2, 3, 4 and 5 years]
• Major Adverse Events (MAEs) [Time frame: At 30, 183 days; 1, 2, 3, 4 and 5 years]

Eligibility criteria

MAIN ARM - Inclusion Criteria:

• 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.

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:

• 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.
• 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

• Must be a man or woman 50 years of age or older by the date of informed consent
• 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.
• 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
• Must be considered, in the judgement 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
• Patient 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 judgement of the S-I, of greater than 2 years

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:

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Yale New Haven Hospital — New Haven
• Dartmouth-Hitchcock Medical Center — Lebanon

Publications

• Crawford ES, Coselli JS. Thoracoabdominal aneurysm surgery. Semin Thorac Cardiovasc Surg. 1991 Oct;3(4):300-22. No abstract available. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 24785682

Identifiers

NCT: NCT02989948 · D18194 · 2000035699

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗