An interventional study of Endovascular treatment of Thoracoabdominal Aortic Aneurysm and Endovascular treatment of Aortic Arch Aneurysms in Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Thoracic and Aortic Dissection, Thoracoabdominal, sponsored by Darren Schneider, M.D.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Darren Schneider, M.D. · Not applicable, Interventional, and Treatment
Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.
To assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery in two study arms:
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's planned enrollment of 520 is above the median of 80 across 41 interventional studies indexed under Aortic Aneurysm, Thoracoabdominal.
Browse Aortic Aneurysm, Thoracoabdominal studies →This is the only study on the registry with Darren Schneider, M.D. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
TAAA STUDY ARM
Inclusion Criteria:
Presence of TAAA in:
Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":
Proximal aortic landing zone:
Mesenteric arteries:
Renal arteries:
Iliac artery access:
For patients with associated common iliac artery aneurysms (>20mm diameter), adequate internal and external iliac artery landing zones and common iliac artery luminal diameter (for iliac branch device use):
Patients deemed high risk for open repair (meeting one, or more, of the following criteria):
Cardiac disease:
Pulmonary disease:
Renal disease:
AORTIC ARCH STUDY ARM
Inclusion Criteria:
Presence of aortic arch aneurysm in:
Suitable arterial anatomy for endovascular aortic arch repair with "Aortic Arch Device":
Proximal aortic landing zone:
Distal aortic landing zone:
Adequate supra-aortic trunk branch landing zone(s):
Innominate artery (if applicable):
Left (or right) common carotid artery (if applicable):
Left (or right) subclavian artery (if applicable):
Iliac artery access:
Patients deemed high risk for open surgical aortic arch repair based upon consensus of both a qualified cardiac surgeon and a qualified vascular surgeon and meeting one, or more, of the following criteria):
APPLIES TO BOTH STUDY ARMS
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Either the Off-the-Shelf TAAA device or the Physician-Specified TAAA Device will be implanted. The Off-the-Shelf TAAA Device is a standard configuration Zenith t-Branch with four branches for the mesenteric arteries and the renal arteries. The Physician-Specified TAAA Devices may include a combination of up to 5 fenestrations and branches for mesenteric and renal arteries. Branches will be used for downward-oriented mesenteric and renal arteries and fenestrations for renal arteries that project laterally or upwards.
Device: Endovascular treatment of Thoracoabdominal Aortic Aneurysm
Physician-specified aortic arch stent graft device with up to 3 antegrade and/or retrograde branches or a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery\] to treat aortic aneurysms involving the aortic arch in patients at high risk for open surgery.
Device: Endovascular treatment of Aortic Arch Aneurysms
A TAAA is an abnormal enlargement (ballooning out) of the main artery (the aorta) and involves all or part of the aorta in your chest as well as all or part of the aorta in the abdomen. It also involves the part of the aorta where the arteries that bring blood to the liver, stomach and intestines and kidneys are attached. This investigational procedure that is being studied uses stent-grafts (cylindrical fabric tubes (grafts), with metal springs (stents) attached). The stent-grafts are placed inside the aneurysmal (weakened) area of the aorta to re-line it. These customized stent-grafts have special branches attached to them or openings (called "fenestrations") that are used to keep blood flowing to the arteries that supply the liver, stomach, intestines and kidneys. The investigational stent graft will be designed and custom-made specifically for your aneurysm.
An aortic arch aneurysm is an abnormal enlargement (ballooning out) of the main artery (the aorta). The ascending aorta and aortic arch is the first part of the vessel as it exits the heart and makes a turn around the area of the collar bone. This part of the aorta gives branches that supply the head, brain and arms. The arch branch endovascular graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively.
Technical Success
Successful deployment of the TAAA device or Physician-Specified TAAA Devices, or Aortic Arch device \& bridging covered stents into all targeted mesenteric \& renal, or supra-aortic arteries with stent-graft \& all branches patent by intraop angiography
Time frame: Intraoperative
Procedural Success
Technical success plus freedom from type I or III endoleak, loss of target vessel patency, death, major stroke, paralysis, new onset permanent hemodialysis, major amputation, \& bowel infarction following deployment of the branched stent-graft.
Time frame: 30 days
Freedom from aneurysm-related mortality at 1 year
Survival from aneurysm-related death.
Time frame: 1 year
Treatment success at 12 months post-procedure
Composite endpoint which includes Technical Success, Procedural Success, and freedom from aneurysm-related mortality
Time frame: 1 year
Target artery patency
Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate target artery patency.
Time frame: Yearly through 5 years
Freedom from all-cause mortality
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN \[Urea Nitrogen\], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.
Time frame: Yearly through 5 years
Freedom from reintervention
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN \[Urea Nitrogen\], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation to determine if reintervention with the device is necessary.
Time frame: Yearly through 5 years
Freedom from endoleak
Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.
Time frame: Yearly through 5 years
Freedom from aneurysm dilatation
Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate aneurysm size.
Time frame: Yearly through 5 years
Freedom from serious adverse events (SAE) and major complications
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN \[Urea Nitrogen\], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.
Time frame: Yearly through 5 years
Freedom from aneurysm rupture and conversion to open repair
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN \[Urea Nitrogen\], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation to determine if aneurysm stability.
Time frame: Yearly through 5 years
Freedom from stent graft migration and branch device migration
Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.
Time frame: Yearly through 5 years
Freedom from major stroke
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN \[Urea Nitrogen\], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.
Time frame: Yearly through 5 years
Freedom from paralysis
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN \[Urea Nitrogen\], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.
Time frame: Yearly through 5 years
Freedom from onset permanent hemodialysis
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN \[Urea Nitrogen\], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.
Time frame: Yearly through 5 years
Freedom from amputation
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN \[Urea Nitrogen\], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.
Time frame: Yearly through 5 years
Freedom from bowel infarction
Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN \[Urea Nitrogen\], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.
Time frame: Yearly through 5 years
Freedom from loss of target vessel patency
Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.
Time frame: Yearly through 5 years
Not enrolling at this site.
Started Nov 2013 (actual). Primary completion is estimated for Dec 2028, 181 months after the start.
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