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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
RECRUITING30 day survival
Percent of patients who survive 30 days following surgery
Time frame: 30 days
Major Adverse Events (MAE) at 30 days following surgery
Percent of patients who development major adverse events at 30-days following surgery including the following: * All-cause mortality * Loss of major organ or system function * Renal failure necessitating hemodialysis * Small or large bowel ischemia necessitating surgical or endovascular intervention * Hepatic ischemia necessitating surgical or endovascular intervention * Gastric ischemia necessitating surgical or endovascular intervention * Paraparesis * Paraplegia * Stroke (Modified Rankin Score of 2 or greater) * Myocardial infarction * Ventilator dependence \> 72 hours * Lower extremity ischemia necessitating surgical or endovascular intervention * Need for surgical or endovascular reintervention
Time frame: 30 days
Treatment success at 12 months following surgery
Percent of patients achieving treatment success through 1 year.
Time frame: 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.
Time frame: 12 months
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.
Time frame: Day of Surgery
Aneurysm rupture
Percent of patients developing aneurysm rupture
Time frame: Day of Surgery
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.
Time frame: Day of Surgery
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.
Time frame: Day of Surgery
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.
Time frame: Day of Surgery
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.
Time frame: Day of Surgery
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
Time frame: Day of Surgery
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.
Time frame: Day of Surgery
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.
Time frame: Day of Surgery
Death during surgery
Percent of patients who die during surgery
Time frame: Day of Surgery
Survival rate
Percent of patients who survive
Time frame: At 30, 183 days; 1, 2, 3, 4 and 5 years
Major Adverse Events (MAEs)
Percent of patients that development MAEs
Time frame: At 30, 183 days; 1, 2, 3, 4 and 5 years
Treatment success
Percent of patients achieving treatment success
Time frame: At 30, 183 days; 2, 3, 4 and 5 years
Aneurysm-Specific Quality of Life Survey
Assessment of quality of life using a validated disease-specific AAA survey. It will be measured using this survey.
Time frame: At Screening, 30, 183 days; 2, 3, 4 and 5 years
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