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Safety and Effectiveness of Physician-Modified Aortic Endografting for Aortic Aneurysms

This study is looking at the safety and effectiveness of a special type of stent-graft called the physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft. This device is used to treat thoracoabdominal aortic aneurysms (TAAAs), which are bulges in the main artery of your body. The study aims to see how well this modified device works compared to traditional open surgery. You may be able to join if you are 50 to 95 years old and have a TAAA that meets certain size requirements for surgery. The study will measure survival and serious problems after 30 days, and overall treatment success after 12 months. The study is currently recruiting 80 participants.

Study design
This is a prospective study with two groups, aiming to enroll 80 participants. It is testing a physician-modified device for aortic aneurysms.
What's involved
Patients who qualify will receive the physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft. They will be followed for 5 years after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after the procedure. Key outcomes are measured at 30 days and 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06501872

Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

Recruiting
NAAges 50–95InterventionalTreatment
Bjoern D. Suckow
~80 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Physician-modified aortic endograft

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
30 day survival
Measured over 30 days
+3 more outcomes measured

Conditions

Aortic Aneurysm

Explore related trials

Aortic Aneurysm

Where it's being run

1 sites across 1 states
New Hampshire1

Study leadership

  • Bjoern D Suckow, MD · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

Who to contact

Amirsadreddin Kazzazi
[email protected]
603-650-6379
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Must be a man or woman 50 years of age or older by the date of informed consent
Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.
Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta)
Must be considered, in the judgement of the Investigator, to be a high- risk candidate for open surgical repair
Must commit to comply with the five-year study assessment schedule of events
Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, of greater than 2 years
Must be a man or woman 50 years of age or older by the date of informed consent
Must have a thoracic, thoracoabdominal, or abdominal aortic aneurysm that necessitates coverage of one or more visceral vessels (celiac, superior mesenteric, or renals) for establishment of proximal and/or distal seal. The aneurysm must not extend proximal to the left subclavian artery, or, in the setting of more proximal disease, that disease must have been previously treated.
Must have an aneurysm size that meets standard size indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta); or, in the judgment of the Investigator, has aneurysm characteristics that portend a high risk of near-term rupture
In the setting of an aortic dissection the following criteria must exist:
Access into the true lumen from the groin and at least one supra-aortic trunk vessel
A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent graft would be anticipated to seal off the dissection lumen
A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen, or surgically created
A true lumen size large enough to deploy the device and still gain access into the target branches
Must be considered, in the judgement of the Investigator, to be a high-risk candidate for open surgical repair
Patient must be able to provide informed consent
Must commit to comply with the five-year study assessment schedule of events
Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, of greater than 2 years

Exclusion

Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection
Ruptured or acutely symptomatic aortic aneurysm
Known connective tissue disorder
Imaging demonstrating any of the following:
Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition)
Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac)
Branch vessel target (renal, superior mesenteric, or celiac) \< 5 mm or \> 10 mm in average diameter
Untreated left subclavian artery stenosis or occlusion
Untreated unilateral or bilateral hypogastric artery occlusion
Signs that the inferior mesenteric artery is indispensable
Have branching, duplication, aneurysm, or untreatable stenosis of the celiac, superior mesenteric artery, or renal arteries that would preclude implantation of the investigational devices
Known allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
History of anaphylaxis to contrast, with inability to prophylax appropriately.
Have uncorrectable coagulopathy
Have unstable angina
Have a body habitus that would inhibit X-ray visualization of the aorta
Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair
Known to be participating in any other clinical study which may affect performance of this - Ability to bear children
Contraindication to oral antiplatelet therapy
Prisoners or those on alternative sentencing
Known systemic infection with potential for endovascular graft infection
Anticipated need for MRI scanning within 3 months of insertion of investigational product
Candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft
Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution.
Known or suspected mycotic aneurysm
Ruptured aneurysm with hemodynamic instability
Known connective tissue disorder
Imaging demonstrating any of the following:
Lack of 20 mm non-aneurysmal proximal seal zone (in either native aorta, elephant trunk graft, or aortic arch endograft)
Lack of 15 mm non-aneurysmal distal seal zone(s) (in either native aortoiliac vessels, prosthetic aortoiliac grafts, or aortoiliac endografts)
Branch vessel target (renal, superior mesenteric, or celiac) \> 10 mm in average diameter
Known allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
History of anaphylaxis to contrast, with inability to prophylax appropriately.
Have uncorrectable coagulopathy
Have a body habitus that would inhibit X-ray visualization of the aorta
Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
Known to be participating in any other clinical study which may affect performance of this device
Ability to bear children
Contraindication to oral antiplatelet therapy
Prisoners or those on alternative sentencing
Known systemic infection with potential for endovascular graft infection
Anticipated need for MRI scanning within 3 months of insertion of investigational product
Candidate for repair under the Instructions for Use of a commercially available, FDA- approved endovascular graft
Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution
Other conditions or comorbidities that, in the opinion of the Investigator, would exclude the patient

What this trial measures

  • 30 day survival30 days

    Percent of patients who survive 30 days following surgery

  • Major Adverse Events (MAE) at 30 days following surgery30 days

    Percent of patients who development major adverse events at 30-days following surgery including the following: * All-cause mortality * Loss of major organ or system function * Renal failure necessitating hemodialysis * Small or large bowel ischemia necessitating surgical or endovascular intervention * Hepatic ischemia necessitating surgical or endovascular intervention * Gastric ischemia necessitating surgical or endovascular intervention * Paraparesis * Paraplegia * Stroke (Modified Rankin Score of 2 or greater) * Myocardial infarction * Ventilator dependence \> 72 hours * Lower extremity ischemia necessitating surgical or endovascular intervention * Need for surgical or endovascular reintervention

  • Treatment success at 12 months following surgery12 months

    Percent of patients achieving treatment success through 1 year.

  • Technical success at 12 months following surgery12 months

    Technical success is assessed 12 months following surgery and is defined as a composite of: successful delivery, without need for unanticipated corrective intervention related to delivery; successful and accurate deployment at the intended implantation site; and successful withdrawal, without need for unanticipated correct intervention related to withdrawal.