Aortic DisordersNCT07064460
Duke Customized Aortic Aneurysm Repair With Endovascular Stent-grafts - Duke CARES Trial
A study testing Physician Modified Endovascular Graft in people with Aortic Disorders, run by Chandler Long, MD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Disorders
- What is being tested?
- Physician Modified Endovascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2026to 11 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 38Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
Ellen Burkett, 919-681-1878, ellen.burkett@duke.edu
About this study
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.
Read the detailed description
The primary objective of the clinical investigation Duke CARES Trial is to assess the use of physician-modification of commercially available, off-the-shelf, endovascular stent-grafts to treat juxtarenal, pararenal and paravisceral complex abdominal aneurysms or thoracoabdominal aneurysms in high-risk for open surgery subjects having appropriate anatomy. The primary intent of the study is to assess safety and efficacy of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Additionally, the study will assess domains for improvement of patient selection criteria, device design, operative techniques, and follow-up regimens to benefit patients undergoing complex endovascular aneurysm repair
Main Study - Statistical Cohort Physician Modified Endovascular Grafts are indicated for endovascular repair of juxtarenal, pararenal, paravisceral and thoracoabdominal aneurysms, in high-risk for open surgery subjects having appropriate anatomy as defined in the eligibility section.
Non-statistical cohort Patients with life-threatening aortic disease who have no acceptable surgical or endovascular alternatives will be allowed to receive treatment under this IDE. Enrollment of these patients under the IDE permits systematic data collection and FDA oversight, while their separation from the primary study cohort preserves the integrity of the safety and effectiveness analyses. This approach provides a treatment option for critically ill patients by offering access to a potential therapeutic option within a regulated and monitored environment without compromising the scientific validity of the trial. The patients in this cohort will follow standard of care, which includes follow-up at 1 month, 6 months and then annually. Data collection and presentation in this cohort will be consistent with the primary study cohort; however, data from this cohort will not be included in the statistical analysis.
- Conditions
- Aortic Disorders
- Being tested
- Physician Modified Endovascular Graft
- Keywords
- aortic disorders, endovascular grafts
- Medical subject headings
- Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician Modified Endovascular GraftDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Physician Modified Endovascular Graft | Experimental | The participant's surgeon will modify a commercially available graft tailored to their anatomy for their surgery. Receives: Device: Physician Modified Endovascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse events (MAE)
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.
Measured: 30 days, or during hospitalization if this exceeds 30 days
Proportion of study participants with treatment success
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
Measured: 1 year
Secondary outcomes (12)
Technical success
Technical success - defined as the successful introduction, deployment and withdrawal of the device, in the absence of surgical conversion or mortality, absence of Type I and III endoleak, absence of branch occlusion ensuring unimpeded flow to the branch vessel(s) intended for preservation or absence of graft limb obstruction.
Measured: Within 24 hours
Incidence of death
Measured: 30 days
Incidence of bowel ischemia
Measured: 30 days
Incidence of myocardial infarction
Measured: 30 days
Incidence of paraplegia
Measured: 30 days
Incidence of renal failure
Measured: 30 days
Incidence of respiratory failure
Measured: 30 days
Incidence of stroke
Measured: 30 days
Estimated procedural blood loss > 1000 cc
Measured: During procedure
Incidence of paraparesis
Measured: 30 days
Proportion of study participants with treatment success
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
Measured: 30 days, 6 months, 2 years, 3 years, 4 years, and 5 years
Proportion of participants who experience any of the specified events
Events include:
- Aneurysm enlargement
- Aneurysm-related mortality
- Aneurysm rupture
- Conversion to open repair
- Secondary intervention for:
- Migration
- Type I (a, b, c) endoleak (See definitions and Figure 1)
- Type III (a, b, c) endoleak (See definitions and Figure 1)
- Device integrity failure (e.g., fracture)
- Patency-related events (i.e., device stenosis or occlusion and embolic events)
- Renal failure
- All-cause mortality
- Endoleaks
- Device integrity failure (e.g., fracture)
- Patency -related events (i.e., endovascular graft or stent component stenosis or occlusion and embolic events)
- Other device-related events
Measured: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start13 Jan 2026
- Primary completion11 Dec 2030 (estimated)
- Study completion11 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chandler Long, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chandler Long, MD, Duke University
- Investigators
- Chandler Long, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064460
- Sponsor's protocol ID
- Pro00116274
- Status last verified
- Jan 2026
- First submitted
- 26 Jun 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duke Customized Aortic Aneurysm Repair With Endovascular Stent-grafts - Duke CARES Trial
- ClinicalTrials.gov ID
- NCT07064460
- Acronym / sponsor ID
- Pro00116274
- Conditions
- Aortic Disorders
- Keywords
- aortic disorders, endovascular grafts
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chandler Long, MDUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 11 Dec 2030 (estimated)
- Study completion
- 11 Dec 2031 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of the clinical investigation Duke CARES Trial is to assess the use of physician-modification of commercially available, off-the-shelf, endovascular stent-grafts to treat juxtarenal, pararenal and paravisceral complex abdominal aneurysms or thoracoabdominal aneurysms in high-risk for open surgery subjects having appropriate anatomy. The primary intent of the study is to assess safety and efficacy of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Additionally, the study will assess domains for improvement of patient selection criteria, device design, operative techniques, and follow-up regimens to benefit patients undergoing complex endovascular aneurysm repair
Main Study - Statistical Cohort Physician Modified Endovascular Grafts are indicated for endovascular repair of juxtarenal, pararenal, paravisceral and thoracoabdominal aneurysms, in high-risk for open surgery subjects having appropriate anatomy as defined in the eligibility section.
Non-statistical cohort Patients with life-threatening aortic disease who have no acceptable surgical or endovascular alternatives will be allowed to receive treatment under this IDE. Enrollment of these patients under the IDE permits systematic data collection and FDA oversight, while their separation from the primary study cohort preserves the integrity of the safety and effectiveness analyses. This approach provides a treatment option for critically ill patients by offering access to a potential therapeutic option within a regulated and monitored environment without compromising the scientific validity of the trial. The patients in this cohort will follow standard of care, which includes follow-up at 1 month, 6 months and then annually. Data collection and presentation in this cohort will be consistent with the primary study cohort; however, data from this cohort will not be included in the statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physician Modified Endovascular Graft | Experimental | Device: Physician Modified Endovascular GraftThe participant's surgeon will modify a commercially available graft tailored to their anatomy for their surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician Modified Endovascular GraftThe 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. | Device | Physician Modified Endovascular Graft |
Primary outcome
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
12 secondary outcomes
Technical success
Time frame: Within 24 hours
Incidence of death
Time frame: 30 days
Incidence of bowel ischemia
Time frame: 30 days
Incidence of myocardial infarction
Time frame: 30 days
Incidence of paraplegia
Time frame: 30 days
Incidence of renal failure
Time frame: 30 days
Incidence of respiratory failure
Time frame: 30 days
Incidence of stroke
Time frame: 30 days
Estimated procedural blood loss > 1000 cc
Time frame: During procedure
Incidence of paraparesis
Time frame: 30 days
Proportion of study participants with treatment success
Time frame: 30 days, 6 months, 2 years, 3 years, 4 years, and 5 years
Proportion of participants who experience any of the specified events
Time frame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chandler Long, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician Modified Endovascular Graft in people with Aortic Disorders, run by Chandler Long, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen R Burkett, MSHS (9196811878, ellen.burkett@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse events (MAE) (time frame: 30 days, or during hospitalization if this exceeds 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.