Aortic Aneurysm
Conditions
Keywords
Aortic Aneurysm
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.
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
Bjoern D. Suckow
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: * 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 judgement of the Investigator, to be a high- risk candidate for open surgical repair * Must commit to comply with the five-year study assessment schedule of events * Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, of greater than 2 years Expanded Selection 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. The aneurysm must not extend proximal to the left subclavian artery, or, in the setting of more proximal disease, that disease must have been previously treated. * 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 Investigator, has aneurysm characteristics that portend a high risk of near-term rupture * In the setting of an aortic dissection the following criteria must exist: * Access into the true lumen from the groin and at least one supra-aortic trunk vessel * A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent graft would be anticipated to seal off the dissection lumen * A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen, or surgically created * A true lumen size large enough to deploy the device and still gain access into the target branches * Must be considered, in the judgement of the Investigator, to be a high-risk candidate for open surgical repair * Patient must be able to provide informed consent * Must commit to comply with the five-year study assessment schedule of events * Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, 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 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 - Ability to bear children * 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 * Candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft * Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution. Expanded Selection
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 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 |
| 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 |
|---|---|---|
| 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. |
| 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 |
| Major Adverse Events (MAEs) | At 30, 183 days; 1, 2, 3, 4 and 5 years | Percent of patients that development MAEs |
| Treatment success | At 30, 183 days; 2, 3, 4 and 5 years | Percent of patients achieving treatment success |
| Aneurysm-Specific Quality of Life Survey | At Screening, 30, 183 days; 2, 3, 4 and 5 years | Assessment of quality of life using a validated disease-specific AAA survey. It will be measured using this survey. |
Countries
United States
Contacts
CONTACTAmirsadreddin Kazzazi
CONTACTCaren Saunders
PRINCIPAL_INVESTIGATORBjoern D Suckow, MD
Dartmouth-Hitchcock Medical Center
Outcome results
None listed