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New treatment option for Aortic Disorders
Official title Duke Customized Aortic Aneurysm Repair With Endovascular Stent-grafts - Duke CARES Trial
ClinicalTrials.gov ID: NCT07064460
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- MAIN COHORT
- 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...
- Extent of aorta to be treated: juxtarenal, pararenal that include 1 or 2 renal and/or accessory renal arteries, paravisceral that includes celiac...
- High risk of morbidity and mortality with open surgical repair as defined by: a. Anatomic Criteria (Previous abdominal surgery; Previous thoracotomy...
- Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a...
You likely can't join 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
See the full eligibility criteria
Who can join
- MAIN COHORT
- 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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 treatment 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 Note: Patients with life-threatening aortic disease who have...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.