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Duke CARES Trial for Aortic Aneurysm Repair

This study, called the Duke CARES Trial, is looking at a new way to repair aortic aneurysms (a bulging in the body's main artery). Surgeons will create a special device called a Physician Modified Endovascular Graft (PMEG) for each patient. This PMEG is made from FDA-approved parts but is custom-fit to your specific anatomy. The goal is to see if these custom grafts are safe and effective for treating aortic disorders. You might be able to join if you have an aneurysm that is larger than 5.5 cm or has grown over time. The study will follow participants for 5 years with regular clinic visits for imaging and blood tests. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 30 participants.
What's involved
You would have regular clinic visits for follow-up imaging and blood tests for 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after treatment, with primary outcomes measured at 30 days and 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07064460

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

Recruiting
NAAges 18+InterventionalTreatment
Chandler Long, MD
~30 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:Physician Modified Endovascular Graft

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of major adverse events (MAE)
Measured over 30 days, or during hospitalization if this exceeds 30 days
+1 more outcome measured

Conditions

Aortic Disorders

Explore related trials

Aortic Aneurysm

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Chandler Long, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Ellen R Burkett, MSHS
[email protected]
9196811878
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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
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:
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
Able to be treated in accordance with the instructions for use with a currently marketed endovascular prosthesis
Subject prefers to receive treatment at another hospital with access to a custom-made endovascular prosthesis
Refusal to give informed consent by the subject or legal representative. Note: Inability to consent prior to surgery will not be exclusionary if it is for life-saving measures.
Known sensitivities or allergies to the materials of construction of the devices will be allowed in a life-threatening situation where the patient would not survive open surgery.

Exclusion

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
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
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
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
Inadequate femoral or iliac access to accommodate the required delivery systems.
Requirement for iliac conduit in cases of inadequate femoral/iliac access
Absence of a suitable non-aneurysmal segment of distal thoracic aorta and significant aortic tortuosity.
Target vessel anatomy not compatible with fenestrated or branched stent graft incorporation, including vessels with severe stenosis, tortuosity and/or insufficient size to accommodate stent graft placement.
Early target vessel bifurcation precluding safe or effective stent graft placement.
Unsuitable iliac artery fixation site and/or anatomy for iliac limb extension or iliac branch device placement, as defined by the device instructions for use

What this trial measures

  • Incidence of major adverse events (MAE)30 days, or during hospitalization if this exceeds 30 days

    The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. MAE include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and estimated procedural blood loss \> 1000 cc.

  • Proportion of study participants with treatment success1 year

    Treatment success requires all the following criteria to be met: * Technical success * Absence of death from the initial procedure, secondary intervention, or aorta-related cause * Absence of persistent type I or type III endoleak * Absence of aneurysm sac expansion \>5 mm * Absence of device migration \>10 mm * Absence of failure due to device integrity issues * Absence of aneurysm rupture * Absence of conversion to open surgical repair * Device infection or thrombosis