RecruitingNot ApplicableNCT05339061

Physician Modified Endograft For Complex Aortic Aneurysm Repair

A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair

Sponsor

University of California, Davis

Enrollment

40 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Complex Abdominal Aortic Aneurysm Juxtarenal Aortic Aneurysm Pararenal Aortic Aneurysm Thoracoabdominal Aortic Aneurysm

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

Min Age: 18 Years

Inclusion Criteria17

Patient is \> 18 years of age
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)
Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form
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
Cannot be treated with a currently available non-modified approved device
High risk for open surgical repair based on any of the factors below:
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
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
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
Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20 mm
Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm.
The resultant repair should preserve patency in at least one hypogastric artery.
Patient has a suitable non-aneurysmal proximal aortic neck diameter between 15 and 42mm
Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm.

Exclusion Criteria20

Patient has a mycotic aneurysm
Patient has a ruptured aneurysm requiring urgent or emergent repair
Patient has a systemic or local infection that may increase the risk of graft infection
Patient has a body habitus that would inhibit X-ray visualization of the aorta.
Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution
Patient has a major surgical or interventional procedure planned within +/- 30 days of the (T)AAA repair.
Patient is currently participating in another investigational device or drug clinical trial.
Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
Patient has a known allergy or intolerance to stainless steel, polyester, polypropylene, nickel, titanium or gold.
Patient has uncorrectable coagulopathy
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)
Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
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 pre-treatment, required treatment, and post-treatment procedures and evaluations.
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 patent hypogastric artery
Shaggy aorta
Patient is not amenable to a temporary or permanent open surgical or endovascular conduit

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEEndovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).

Modification * Deploy the graft on the sterile, surgical table * Mark out on the graft the locations of the fenestrations on the graft adjusting as necessary * Using handheld electrocautery, fashion the fenestration in the appropriate location on the moistened graft material in order to prevent inadvertent progression of the fenestration size * If the fenestration is going to remain as such, then a snare is used to fashion the marker on the fenestration with 5-0 stitch * If the fenestration is going to be made into a branch, then an appropriately sized, self-expanding stent is beveled and fashioned to be 15 mm long and sewn to the fenestration in addition to a snare with the 5-0 stitch * Two orientation markers are placed at the proximal edge and distal edge of the graft consisting of portions of the snare sewn to the anterior portion of the graft in a J fashion with a 5-0 stitch