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Study of Surgeon-Modified Stent Grafts for Complex Aortic Aneurysms

This study is looking at the safety and effectiveness of surgeon-modified stent grafts (Cook Zenith devices like Zenith Flex, Zenith Fenestrated, and Cook Alpha Thoracic Endovascular Graft) to treat complex aortic aneurysms. These are bulges in the body's main artery (aorta) that are difficult to treat with standard methods, especially if you've had a previous repair that failed (failed EVAR). The study aims to see if these custom-made grafts can prevent deaths related to the aneurysm and all causes of death over five years. You might be able to join if you are 18 or older and have an aortic aneurysm that is a certain size or has grown over time. This study is currently unclear on its recruitment status, but plans to enroll 25 participants.

Study design
This is a non-randomized study evaluating an intervention. It plans to enroll 25 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for five years after the intervention to assess outcomes.

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

NCT05531084

Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Jesse Manunga, MD
~25 participants
Updated 2022-10-06 on ClinicalTrials.gov
What's tested:Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevention of aortic aneurysm related mortality and all cause mortality post intervention
Measured over 5 years

Conditions

Thoracoabdominal Aneurysm
Juxtarenal Aortic Aneurysm
Pararenal Aneurysm
Aortic Aneurysm
Failed Previous Infrarenal Repairs (Failed EVAR)

Explore related trials

Aortic AneurysmFailed Previous Infrarenal RepairsJuxtarenal aortic aneurysmPararenal AneurysmThoracoabdominal aortic aneurysm

Where it's being run

1 sites across 1 states
Minnesota1

Who to contact

Jesse Manunga, MD, FSVS, FACS
[email protected]
612-863-6800
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age: ≥ 18 years old
The subject has one or more of the following:
American Association of Anesthesiologists grading system: subjects with ASA scores of 3-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.
SVS/AAVS grading system: high risk (8-20% mortality risk) subjects will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; prohibitive high risk (31-70% mortality risk) subjects will be excluded.
American Association of Anesthesiologists (ASA) physical status classification system: subjects with ASA scores of 1-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.
Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical conduit
Extent of aorta to be treated: infrarenal aortic aneurysms with \< 10 mm neck length, juxtarenal or pararenal aneurysms that include 1 or 2 renal arteries; paravisceral and extent IV-V thoracoabdominal aneurysms, Extent I-III thoracoabdominal aneurysm including those patients requiring a carotid-left subclavian bypass in order to achieve, at least, 20 mm of proximal landing zone
Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:
Minimum branch vessel diameter of 5 mm or greater Iliac artery distal fixation site greater than 45 mm in length and diameter in the range of 8 mm to 17 mm
Can be treated in accordance with the instructions for use with a commercially approved and marketed endovascular prosthesis
Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site with the exception of percutaneous aortic valve surgery
Unwilling or unable to comply with the follow-up schedule
Inability or unwillingness of patient or patient's legally authorized representative to provide informed consent.
Subject is pregnant or breastfeeding
Known sensitivities or allergies to the materials of construction of the devices, including but not limited to titanium and PTFE.
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
Subject has had a 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)
Systemic or local infection that may increase the risk of endovascular graft infection
Baseline creatinine greater than 2.0 mg/dL

Exclusion

Age: \< 18 years old

What this trial measures

  • Prevention of aortic aneurysm related mortality and all cause mortality post intervention5 years

    Primary outcome criteria: * Mortality related to primary aortic disease and intervention * All-cause mortality post intervention