NCT07064460 · Chandler Long, MD
Duke Customized Aortic Aneurysm Repair With Endovascular Stent-grafts - Duke CARES Trial
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Physician Modified Endovascular Graft
The participant's surgeon will modify a commercially available graft tailored to their anatomy for their surgery. All components used to create the final device (PMEG), made specifically for each participant and tailored to their individual anatomy, are FDA-approved, although the final graft itself (the PMEG) is considered investigational.
Primary outcome measures
Incidence of major adverse events (MAE)
Time frame: 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 success
Time frame: 1 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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 Note: Patients with life-threatening aortic disease who have no acceptable surgical or endovascular alternatives will be allowed to receive treatment under this IDE in the non-statistical cohort Non-statistical Cohort This cohort will include patients who meet the inclusion criteria and meet any of the above exclusion criteria\
- with the exception of the following:
- 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.
Where
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 4, 2026 · Source of record for eligibility and locations