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

NCT07064460 | Recruiting FDA Device

• 1 other identifier: Pro00116274
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aortic Disorders

Keywords

aortic disorders; endovascular grafts

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  1 year

Secondary Outcomes (12)

• Technical success

  Within 24 hours

• Incidence of death

  30 days

• Incidence of bowel ischemia

  30 days

• Incidence of myocardial infarction

  30 days

• Incidence of paraplegia

  30 days

Study Arms (1)

Physician Modified Endovascular Graft

EXPERIMENTAL

The participant's surgeon will modify a commercially available graft tailored to their anatomy for their surgery.

Device: Physician Modified Endovascular Graft

Interventions

Physician Modified Endovascular Graft DEVICE

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.

Physician Modified Endovascular Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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
• 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)

Sponsors & Collaborators

• Chandler Long, MD: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Aortic Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chandler Long, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen R Burkett, MSHS

CONTACT

9196811878; ellen.burkett@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 14, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): December 11, 2030
• Study Completion (Estimated): December 11, 2031
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)