Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
NCT Number: NCT06501872
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aortic Aneurysm
Interventions: DEVICE: Physician-modified aortic endograft
Sponsor: Bjoern D. Suckow
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2031-09
Locations: Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States

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.

Primary Outcome Measures: 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 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, 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 Outcome Measures: 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., Day of Surgery|Aneurysm rupture, Percent of patients developing aneurysm rupture, 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., 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., 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., 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., 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, 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., 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., Day of Surgery|Death during surgery, Percent of patients who die during surgery, Day of Surgery|Survival rate, Percent of patients who survive, At 30, 183 days; 1, 2, 3, 4 and 5 years|Major Adverse Events (MAEs), Percent of patients that development MAEs, At 30, 183 days; 1, 2, 3, 4 and 5 years|Treatment success, Percent of patients achieving treatment success, 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., At Screening, 30, 183 days; 2, 3, 4 and 5 years