Duke Customized Aortic Aneurysm Repair With Endovascular Stent-grafts - Duke CARES Trial

Recruiting now · Not applicable

Conditions studied: Aortic Disorders

In brief

The purpose of this study is to see if physician modified endovascular grafts (PMEG) can be used safely for the treatment of aortic disorders. The surgeon will modify a commercially available graft tailored to the participant's anatomy for surgery. The researchers will follow participants for 5 years, which will require regular visits to the clinic for follow-up imaging and follow-up blood tests.

Key facts

Study ID

NCT07064460

Run by

Chandler Long, MD

People needed

30

Starts

2026-01-13

Expected to finish

2031-12-11

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A participant may be entered into the study if the participant has at least one of the following: An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e, perpendicular to the centerline) measurements; Aneurysm with a history of growth > 0.5 cm in 6 months; Saccular aneurysm deemed at significant risk for rupture; Symptomatic aneurysm; Ruptured aneurysm
• AND
• Extent of aorta to be treated: juxtarenal, pararenal that include 1 or 2 renal and/or accessory renal arteries, paravisceral that includes celiac artery and/or superior mesenteric artery, and/or thoracoabdominal
• High risk of morbidity and mortality with open surgical repair as defined by:
• a. Anatomic Criteria (Previous abdominal surgery; Previous thoracotomy; Previous aortic surgery) b. Physiologic Criteria (ASA Category III or higher; Age >70 years; Previous myocardial infarction, coronary artery disease, or coronary artery stent; Coronary stress test with a reversible perfusion defect; Congestive heart failure (CHF); Chronic obstructive pulmonary disease (COPD))
• Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
• Nonaneurysmal aortic segment proximal to the aneurysm (neck) with a minimum neck length of 25 mm (Diameter in the range of 18 mm - 42 mm; Angle less than 60o relative to the axis of the aneurysm; Angle less than 60o relative to the axis of the suprarenal aorta);
• Minimum branch vessel diameter greater than 5 mm
• Iliac artery distal fixation site greater than 20 mm in length and diameter in the range of 9 mm - 21 mm (for use of ZFEN)
• Contralateral iliac artery distal fixation site greater than 20 mm in length and diameter in the range of 7.5 mm - 20 mm.
• Age: ≥ 18 years old
• Life expectancy: > 2 years

You may not qualify if…

• GENERAL EXCLUSION CRITERIA:
• Able to be treated in accordance with the instructions for use with a currently marketed endovascular prosthesis
• Unwilling to comply with the follow-up schedule
• Inability or refusal to give informed consent by subject or legal representative
• Pregnant or breastfeeding
• Prefers to receive treatment at another hospital with access to a non-physician modified endovascular prosthesis
• Refusal of blood transfusions for religious or personal reasons
• Participation in another investigational clinical or device trial, with the exception of another investigational endovascular stent-graft protocol or percutaneous aortic valve protocol, not encompassed by the IDE protocol and performed remotely from the fenestrated procedure (> 30 days). Examples include remote (>30 days) participation in a thoracic, abdominal or iliac branch device trial, or participation in a percutaneous aortic valve trial.
• Mycotic aneurysm or evidence of active systemic infection
• MEDICAL EXCLUSION CRITERIA:
• Known sensitivities or allergies to the materials of construction of the devices, including nitinol (nickel, titanium), polyester, polypropylene, gold, stainless steel, and/or solder (tin, silver).
• Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
• Uncorrectable coagulopathy
• Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
• Morbid obesity (BMI ≥ 40 or BMI 30-39.9 with comorbidities)
• Major surgical or interventional procedure unrelated to the treatment of the aneurysm planned < 30 days of the endovascular repair
• Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
• Baseline creatinine greater than 2.0 mg/dL
• History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
• Deemed a high risk due to significant comorbidities, adjudicated by severity according to the Society for Vascular Surgery reporting standards for endovascular aortic repair involving the renal-mesenteric arteries
• ANATOMICAL EXCLUSION CRITERIA:
• Thrombus or excessive calcification within the neck of the aneurysm
• Presence of significant thrombus and/or excessive calcification within the intended proximal or distal seal zone of the aneurysm.
• Branch stenosis > 75% (if left untreated)
• Anatomy that would not allow maintenance of at least one patent hypogastric artery

Where it is running

• Duke University Health System — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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