Aortic Aneurysm, Thoracoabdominal
Conditions
Keywords
endovascular, physician-modified, graft, fenestration
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.
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
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.
Sponsors
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
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. 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. 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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 day survival | 30 Days | Percent of patients who survive 30 days following surgery |
| Major Adverse Events (MAE) at 30 days following surgery | 30 Days | Percent of patients who development major adverse events |
| Treatment success at 12 months following surgery | 12 Months | Percent of patients achieving treatment success through 1 year |
| Technical success at 12 months following surgery | 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access site complication (Femoral or Iliac) | Day of Surgery | 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. |
| Lower extremity ischemia | Day of Surgery | 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. |
| Lower extremity compartment syndrome | Day of Surgery | 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. |
| Stroke | Day of Surgery | 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. |
| Paraplegia | Day of Surgery | 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. |
| Paraparesis | Day of Surgery | 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. |
| Death during surgery | Day of Surgery | Percent of patients who die during surgery |
| Survival rate | At 30, 183 days; 1, 2, 3, 4 and 5 years | Percent of patients who survive |
| Treatment success | At 30, 183 days; 2, 3, 4 and 5 years | Percent of patients achieving treatment success |
| Major Adverse Events (MAEs) | At 30, 183 days; 1, 2, 3, 4 and 5 years | Percent of patients that development MAEs |
| Technical success on the day of surgery | 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. |
| Aneurysm rupture | Day of Surgery | Percent of patients developing aneurysm rupture |
| Conversion to open repair | Day of Surgery | 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. |
Countries
United States
Contacts
CONTACTDavid P. Kuwayama, M.D., MPA
PRINCIPAL_INVESTIGATORDavid P. Kuwayama, M.D., M.P.A.
Yale University
Outcome results
None listed