Juxtarenal Aortic AneurysmNCT06526676
Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts
A study testing Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft in people with Juxtarenal Aortic Aneurysm and Pararenal Aneurysm, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to evaluate safety and effectiveness of endovascular treatment of juxtarenal, pararenal and thoracoabdominal aortic aneurysms (with or without iliac artery involvement) using physician-modified stent grafts with a combination of fenestrations and/or branches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Juxtarenal Aortic Aneurysm, Pararenal Aneurysm, Thoracoabdominal Aortic Aneurysm
- What is being tested?
- Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient may be included in the study if at least one of the following is present and is considered appropriate for treatment with a physician modified stent graft. Patients must be deemed high risk for traditional open surgical repair, if any of the following conditions are present.
- Patients will be deemed physiologically high risk if any of the following conditions are present:
- Older than 75 years of age
- Chronic obstructive pulmonary disease
- Congestive heart failure
- Previous myocardial infarction, coronary stent, or bypass
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- Chronic renal insufficiency with baseline eGFR < 40 ml/min
- American Society of Anesthesiologist (ASA) score > 3
- Patient will be deemed anatomically high risk if any of the following conditions are present:
- Prior intraabdominal operation(s)
- Prior abdominal wall reconstructions. (ie. Ventral hernia repairs)
- Prior radiation therapy targeting abdomen and/or pelvis
- History of intraabdominal sepsis. (ie. Diverticulitis managed with percutaneous drainage)
- Patients will then be included in one of three arms with the inclusion criteria specified as follows:
- Arm 1 (Short neck infrarenal, juxtarenal, suprarenal and extent IV TAA)
- Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aortic aneurysm or dissection with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.
- Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aneurysm with a history of growth ≥ 0.5 cm in one year.
- Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
- Presence of juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aortic aneurysm not meeting one of the above-mentioned criteria with or without unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.5-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.
- Arm 2 (Thoracoabdominal aortic aneurysms)
- Extent I, II, or III thoracoabdominal aortic aneurysm or dissection with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.
- Extent I, II, or III thoracoabdominal aortic aneurysm with a history of growth ≥ 0.5 cm in one year.
- Extent I, II, or III thoracoabdominal saccular aortic aneurysms deemed at significant risk for rupture based upon physician interpretation.
- Presence of Extent I, II, or III thoracoabdominal aortic aneurysm not meeting one of the above-mentioned criteria with or without unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.5-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.
- Arm 3 (Urgent or emergent aneurysms) o Ruptured, contained ruptured or symptomatic juxtarenal, pararenal, suprarenal or thoracoabdominal aortic aneurysm planned to receive urgent or emergent repair within 48 hours of clinical encounter, in patients able to provide informed consent and deemed not a reasonable candidate for open surgery or repair with any commercially available device.
Who cannot join
- Patients must be excluded from the study if any of the following conditions are true:
- Less than 18 years of age
- Unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent by the patient or a legally authorized representative
- Pregnant or breastfeeding
- Life expectancy < 2-years
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- Prior open surgical or interventional procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, cervical debranching, elephant trunk repair), to facilitate the procedure by allowing open revascularization of a target artery not amenable to revascularization with the investigational device, such as an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement of alignment side stents.
- Patients eligible for treatment with any FDA-approved marketed device within its instructions for use
- Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufactured-made device at another institution
- Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and/or use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be 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. Participation in medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated-branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair.
- Medical Exclusion Criteria:
- Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, PTFE, urethane, or gold.
- History of anaphylactic reaction to contrast material that cannot be adequately pre-medicated.
- Uncorrectable coagulopathy.
- Mycotic aneurysm or patients with evidence of active systemic infection.
- History of connective tissue disorder (e.g vascular Ehlers Danlos, Marfan's syndrome), except for those patients who had prior open surgical aortic replacement, where a surgical graft would serve as landing zone for the investigational stent-graft, those who are deemed prohibitive risk for open surgical repair or connective tissue disorders with no effect of vascular system (e.g non-vascular Ehlers Danlos).
- Body habitus that would inhibit X-ray visualization of the aorta and its branches.
- Anatomic Exclusion Criteria
- Inadequate femoral or iliac access compatible with the required delivery systems.
- Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral/iliac access.
- Absence of a non-aneurysmal aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with:
- A diameter measured outer wall to outer wall of no greater than 42mm and no less than 21 mm;
- Parallel aortic wall with <20% diameter change and without significant calcification and/or thrombus in the selected area of seal zone
- Visceral vessel anatomy not compatible with fenestrated/branched stent graft visceral vessel incorporation due to excessive occlusive disease or small size not amenable to stent graft placement
- Unsuitable distal iliac artery fixation site and anatomy for iliac limb extension or iliac branch device as per devices' instructions for use (IFU)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Kate M Horiuchi, MPH, (310) 267-1039, khoriuchi@mednet.ucla.edu
Bernardo C Mendes, MD
About this study
Official title: Clinical Outcomes and Predictors of Major Adverse Events in Patients Treated for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts
The purpose of this study is to evaluate safety and effectiveness of endovascular treatment of juxtarenal, pararenal and thoracoabdominal aortic aneurysms (with or without iliac artery involvement) using physician-modified stent grafts with a combination of fenestrations and/or branches.
- Being tested
- Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent GraftDevice
Physician-modified stent grafts that utilizes multiple stent grafts with a combination of fenestrations and/or branches
| Study group | Role | What they receive |
|---|---|---|
| Subjects with short neck infrarenal, juxtarenal, suprarenal and extent IV TAA | Experimental | Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft Receives: Device: Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft |
| Subjects with thoracoabdominal aortic aneurysms | Experimental | Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft Receives: Device: Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft |
| Subjects with urgent or emergent aneurysms | Experimental | Subjects will have their aortic aneurysms repaired using an investigational physician-modified graft Receives: Device: Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with major adverse events
Total number of patients to experience a major adverse event as defined as any cause mortality, bowel ischemia (requiring surgical therapy), type I myocardial infarction (rise of troponin levels at least 1 value above 99th percentile of upper limit and with at least one of the following: symptoms of acute myocardial ischemia, new ischemic ECG changes, development of new pathological Q waves, imaging evidence of loss of viable myocardium or new regional wall motion abnormalities, or identification of coronary thrombus by angiography or by autopsy), paraplegia (Level 3), renal failure (need for renal replacement therapy or > 50% decline in eGFR), respiratory failure (respiratory failure requiring ventilatory support > 24 hours or re-intubation), major stroke.
Measured: 30 days
Treatment success
Total number of patients to achieve treatment success as defined by: technical success, defined as successful delivery, deployment and withdrawal of the physician-modified endovascular graft with preservation and patency of those branch vessels intended to be preserved; freedom from aneurysm enlargement >5 mm; freedom from secondary interventions for type I or type III endoleak, stent-graft migration, device integrity failure (e. g., fracture), and patency-related events; and freedom from aneurysm rupture or conversion to open repair.
Measured: 12 months
Secondary outcomes (1)
Change in Quality of Life
The Short Form Health Survey (SF-36) is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability.
Measured: Baseline, 30 days, 6 months, and annually at 1, 2, 3, 4 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start2 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juxtarenal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernardo Mendes, MD, University of California, Los Angeles
- Investigators
- Bernardo C Mendes, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526676
- Sponsor's protocol ID
- 25-1031
- Status last verified
- Dec 2025
- First submitted
- 3 Jun 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes and Predictors of Major Adverse Events in Patients Treated for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts
- ClinicalTrials.gov ID
- NCT06526676
- Acronym / sponsor ID
- 25-1031
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety and effectiveness of endovascular treatment of juxtarenal, pararenal and thoracoabdominal aortic aneurysms (with or without iliac artery involvement) using physician-modified stent grafts with a combination of fenestrations and/or branches.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with short neck infrarenal, juxtarenal, suprarenal and extent IV TAA | Experimental | Device: Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent GraftSubjects will have their aortic aneurysms repaired using an investigational physician-modified graft |
| Subjects with thoracoabdominal aortic aneurysms | Experimental | Device: Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent GraftSubjects will have their aortic aneurysms repaired using an investigational physician-modified graft |
| Subjects with urgent or emergent aneurysms | Experimental | Device: Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent GraftSubjects will have their aortic aneurysms repaired using an investigational physician-modified graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- A patient may be included in the study if at least one of the following is present and is considered appropriate for treatment with a physician modified stent graft. Patients must be deemed high risk for traditional open surgical repair, if any of the following conditions are present.
- Patients will be deemed physiologically high risk if any of the following conditions are present:
- Older than 75 years of age
- Chronic obstructive pulmonary disease
- Congestive heart failure
Key exclusion criteria (25 listed)
- Less than 18 years of age
- Unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent by the patient or a legally authorized representative
- Pregnant or breastfeeding
- Life expectancy < 2-years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent GraftPhysician-modified stent grafts that utilizes multiple stent grafts with a combination of fenestrations and/or branches | Device | Subjects with short neck infrarenal, juxtarenal, suprarenal and extent IV TAA, Subjects with thoracoabdominal aortic aneurysms, Subjects with urgent or emergent aneurysms |
Primary outcome
Number of patients with major adverse events
Time frame: 30 days
Total number of patients to experience a major adverse event as defined as any cause mortality, bowel ischemia (requiring surgical therapy), type I myocardial infarction (rise of troponin levels at least 1 value above 99th percentile of upper limit and with at least one of the following: symptoms of acute myocardial ischemia, new ischemic ECG changes, development of new pathological Q waves, imaging evidence of loss of viable myocardium or new regional wall motion abnormalities, or identification of coronary thrombus by angiography or by autopsy), paraplegia (Level 3), renal failure (need for renal replacement therapy or > 50% decline in eGFR), respiratory failure (respiratory failure requiring ventilatory support > 24 hours or re-intubation), major stroke.
Treatment success
Time frame: 12 months
Total number of patients to achieve treatment success as defined by: technical success, defined as successful delivery, deployment and withdrawal of the physician-modified endovascular graft with preservation and patency of those branch vessels intended to be preserved; freedom from aneurysm enlargement >5 mm; freedom from secondary interventions for type I or type III endoleak, stent-graft migration, device integrity failure (e. g., fracture), and patency-related events; and freedom from aneurysm rupture or conversion to open repair.
1 secondary outcome
Change in Quality of Life
Time frame: Baseline, 30 days, 6 months, and annually at 1, 2, 3, 4 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernardo C Mendes, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cook Alpha TX2 Stent Graft, Cook Zenith TX2, and Cook Zenith Fenestrated Stent Graft in people with Juxtarenal Aortic Aneurysm and Pararenal Aneurysm, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate M Horiuchi, MPH ((310) 267-1039, khoriuchi@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with major adverse events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.