NCT05339061 Physician Modified Endograft For Complex Aortic Aneurysm Repair

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 40 participants in total. It began in 2023-03-01 with a primary completion date of 2028-12.

Brief Summary

The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.

Eligibility Criteria

---Inclusion criteria--- 1. Patient is \> 18 years of age 2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study) 3. Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form 4. Patient has a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysm (Extent I-V) that meets at least one of the following: * Aortic aneurysm with diameter ≥ 5.5cm * Aortic aneurysm with a history of growth ≥0.5cm in the last 6 months * Symptomatic aortic aneurysm 5. Cannot be treated with a currently available non-modified approved device 6. High risk for open surgical repair based on any of the factors below: 1. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery 2. Physiologic i. ASA Category III or higher ii. Age \>70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD 7. Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft or is suitable for an iliac conduit 8. Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20 mm 9. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm. 10. The resultant repair should preserve patency in at least one hypogastric artery. 11. Patient has a suitable non-aneurysmal proximal aortic neck diameter between 15 and 42mm 12. Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm. ---Exclusion Criteria--- -General Exclusion Criteria- 1. Patient has a mycotic aneurysm 2. Patient has a ruptured aneurysm requiring urgent or emergent repair 3. Patient has a systemic or local infection that may increase the risk of graft infection 4. Patient has a body habitus that would inhibit X-ray visualization of the aorta. 5. Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution 6. Patient has a major surgical or interventional procedure planned within +/- 30 days of the (T)AAA repair. 7. Patient is currently participating in another investigational device or drug clinical trial. -Medical Exclusion Criteria- 1. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment. 2. Patient has a known allergy or intolerance to stainless steel, polyester, polypropylene, nickel, titanium or gold. 3. Patient has uncorrectable coagulopathy 4. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina) 5. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome). 6. Patient has active malignancy with life expectancy of less than 2 years 7. Patient has a limited life expectancy of less than 2 years. 8. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations. -Anatomic Exclusion Criteria- 1. Significant occlusive disease, tortuosity or calcification that would prevent endovascular access 2. Proximal seal site with a circumferential thrombus/atheroma 3. Inability to maintain at least one patent hypogastric artery 4. Shaggy aorta 5. Patient is not amenable to a temporary or permanent open surgical or endovascular conduit

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