This single-arm FDA-monitored protocol intends to broaden endovascular device applicability using physician-modifications in patients who A) Have anatomical conditions not amenable to endovascular repair using currently marketed grafts in the United States. B) Are at high risk for open surgical repair. C) Are high-risk subjects with previously placed endovascular devices and have developed failure…
This single-arm FDA-monitored protocol intends to broaden endovascular device applicability using physician-modifications in patients who A) Have anatomical conditions not amenable to endovascular repair using currently marketed grafts in the United States. B) Are at high risk for open surgical repair. C) Are high-risk subjects with previously placed endovascular devices and have developed failure of their previous devices. The use of physician-modified endografts aims to shift the seal zone proximally above the celiac artery in order to treat their complex or thoracoabdominal aneurysms in a minimally invasive fashion. These patients are considered too high risk to survive open surgical repair and do not meet anatomic criteria for the Gore Thoracoabdominal Multi Branch Endoprosthesis, which is currently the only FDA approved device in the US to treat these aneurysms.
The primary objective is to evaluate safety and effective of physician modified endografts in the treatment of thorax-abdominal aneurysms and complex aortic aneurysms. For primary safety endpoints, mortality and major adverse events (MAE) will be analyzed at 30 days or in hospitalization (if this exceeds 30 days). Primary endpoints include the following: 1. Mortality related to primary aortic disease 2. Aneurysm rupture 3. All cause mortality
For primary effectiveness endpoints, treatment success will be analyzed as the proportion of patients to achieve treatment success at 12 months. Treatment success is defined by a composite endpoint, which includes all of the following criteria: Technical success (defined as successful delivery and deployment of the physician modified endograft with perseveration of those branch vessels intended to be preserved, freedom from type I or type III endoleak, freedom from stent graft migration, freedom from aneurysm enlargement \>5mm, freedom from aneurysm rupture or conversion to open repair.
Secondary objectives of the study include assessment of individual safety and effectiveness endpoints as follows: technical success, procedure success, mortality, major adverse events - specifically renal, cardia, pulmonary, gastrointestinal, and neurologic. Each endpoint will be analyzed separately. Secondary endpoints will be individually analyzed at 4-8 weeks, 6 months, and annually at 1,2,3,4, and 5 years.
Secondary endpoints to be analyzed are the following: 1. Evidence of Aortic Disease Progression: Monitoring for aneurysm growth \> 5 mm from baseline measurements. 2. Device Failure: Evaluation of device performance, including migration \> 10 mm, device degradation, and loss of device integrity. 3. Endoleaks: Monitoring for the occurrence and classification of endoleaks as outlined in the clinical outcome definitions. 4. Secondary Interventions: Description and analysis of secondary interventions aimed at treating branch vessel stenosis, occlusion, or embolization. 5. Significant Lifestyle-Limiting or Disabling Complications: Assessment and reporting of complications resulting in significant impairment of daily life, such as stroke-induced paralysis (paraplegia). 6. Cardiac Dysfunction: Monitoring and analysis of cardiac events, including myocardial infarction, congestive heart failure, and cardiac ischemia requiring intervention. 7. Renal Events: Evaluation of renal complications, including the need for dialysis, deterioration of renal function, and renal failure. 8. Mesenteric Events: Description and classification of mesenteric complications, such as ischemia and the need for surgical resection. 9. Respiratory Events: Monitoring for respiratory complications, including respiratory failure and prolonged intubation
Secondary endpoints will be individually analyzed at 4-8 weeks, 6 months, and annually at 1,2,3,4, and 5 years
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Eligibility Criteria
Inclusion Criteria:
* Patient is \> 18 years of age.
* Patients who are male or non-pregnant female (females of childbearing potential must have a negative pregnancy test prior to enrollment into the study)
* Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed …
Inclusion Criteria:
* Patient is \> 18 years of age.
* Patients who are male or non-pregnant female (females of childbearing potential must have a negative pregnancy test prior to enrollment into the study)
* Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form
* The subject has at least one of the following:
1. . An aortic or aortoiliac aneurysm with a maximum diameter of ≥ 5.5cm for males, ≥ 5.0cm for females
2. Aortic Aneurysm with a history of growth ≥ 0.5 cm in 6 mos.
3. Symptomatic aneurysm
4. Morphology such as saccular aneurysms
5. Aneurysms meeting any of the above criteria a-e above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.
* Cannot be treated with a currently available non-modified approved device.
* Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified graft or is suitable for an iliac conduit.
* Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20mm.
* Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥15mm.
* The resultant repair should preserve patency in at least one hypogastric artery.
* Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20mm.
* Chronic Dissection with aneurysmal degeneration that meets size criteria as described above for repair
* Type 1A endoleak requiring extension above the previous repair into the pararenal or paravisceral portion of the aorta to achieve 2 cm of seal.
Exclusion Criteria:
* patient has a mycotic aneurysm
* patient has a systemic or local infection that may increase the risk of graft infection.
* Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment.
* Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair.
* Patient is currently participating in another investigational device or drug clinical trial.
* Eligible for treatment with FDA-approved marketed device
* Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturermade device at another institution.
* Unwilling to comply with the follow-up schedule.
* Inability or refusal to give informed consent by subject or legal representative. - The subject is pregnant or breastfeeding.
* Known sensitivities or allergies to the materials of construction of the devices, including stainless steel, polyester, polypropylene, nickel, titanium, or gold. - Known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pretreatment
* Uncorrectable coagulopathy
* Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
* Systemic or local infection that may increase the risk of endovascular graft infection.
* History of connective tissue disorders (e.g., Marfan Syndrome, Ehlers's Danlos Syndrome) without landing zone created from graft via previous open repair. - Patient has active malignancy with life expectancy of less than 2 years.
* Patient has a limited life expectancy of less than 2 years.
* Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pretreatment, required treatment, and post-treatment procedures and evaluations.
* Anatomical exclusion criteria such as significant occlusive disease, tortuosity or calcification that would prevent endovascular access.
* proximal seal site with a circumferential thrombus/atheroma
* inability to maintain at least one hypogastric artery.
* shaggy aorta
* patient is not amenable to a temporary or permanent open surgical or endovascular conduit.
* Thrombus or excessive calcification within the neck of the aneurysm
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