Juxtarenal Aortic AneurysmPMEGNCT06657794
Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms
A study testing Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system in people with Juxtarenal Aortic Aneurysm and Aortic Rupture, run by The Cleveland Clinic.
Trial summary
The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Juxtarenal Aortic Aneurysm, Aortic Rupture
- What is being tested?
- Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 17 Feb 2025to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Patient is ≥ 18 years of age
- Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
- Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
- Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:
- An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
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- Aneurysm with a history of growth > 0.5 cm in 6 months
- Saccular aneurysm deemed at significant risk for rupture
- Symptomatic aneurysm
- Ruptured aneurysm
- Patient has patent iliac or femoral arteries, with or without the use of conduit, that will allow endovascular access with the physician modified endovascular graft.
- Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.
- Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15mm. The resultant repair should preserve patency in at least one hypogastric artery.
- Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32 mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.
- Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
- Patient has juxtarenal aortic neck angulation ≤ 60°
- Target branch vessel diameter ≥ 5 mm.
- Patient must be willing to comply with all required follow-up exams.
Who cannot join
- Patients that meet ANY of the following are not eligible for enrollment into the study:
- Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection
- Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
- Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
- Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).
- Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
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- Patient has known allergy or intolerance to stainless steel, nitinol or gold (gold-coated tungsten).
- Patient has a body habitus that would inhibit X-ray visualization of the aorta
- Patient has a limited life expectancy of less than 1 year
- Patient is currently participating in another investigational device or drug clinical trial
- Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pretreatment, required treatment, and post-treatment procedures and evaluations.
- Thrombus or excessive calcification within the neck of the aneurysm
- Branch vessel stenosis ≥ 80%
- Patient treatable on label with FDA approved EVAR or FEVAR device and can wait for device availability.
- Subject is willing and eligible to enroll in a manufacturer-sponsored study at the investigational site, or the subject is willing and eligible to participate in a study with a manufacturer-made device at another institution.
About this study
Official title: Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms
The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device:
- acutely (i.e., treatment success and technical success);
- at 30 days (i.e., the rate of major adverse events (MAE)); and
- at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Read the detailed description
The primary objective of the clinical investigation Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
- Conditions
- Juxtarenal Aortic Aneurysm, Aortic Rupture
- Being tested
- Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system
- Medical subject headings
- Aortic Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft systemDevice
A Physician Modified Endograft is a commercially available, off-the-shelf endograft that has been altered at the time of the procedure by creating fenestrations in the seal zone of the graft to preserve blood flow into vital branch vessels. These fenestrations are marked with medical grade gold markers to facilitate fluoroscopic visualization during the procedure. In order to prevent branch vessel occlusion, these branch vessels are typically stented with covered balloon expandable stents using standardized techniques.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system Receives: Device: Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events
The proportion of patients that experience a rate of Major Adverse Events
Measured: Up to 30 days
Effectiveness
Technical Success, defined as successful delivery and deployment of the physician modified endovascular graft with preservation of those branch vessels intended to be preserved.
- Freedom from Type I \& III endoleaks
- Freedom from stent graft migration
- Freedom from abdominal aortic aneurysm enlargement
- Freedom from Aortic aneurysm rupture and conversion to open repair
Measured: Up to 12 months
Secondary outcomes (9)
Occurrence of the safety events
- Mortality
- Aneurysm related mortality
- Aneurysm rupture
- Major Adverse Events
- Renal failure with or without permanent dialysis
- Graft infection
Measured: Up to 5 years
Technical Success
Technical Success is a composite of the following:
- Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits
- Successful delivery and deployment at the intended implantation site
- Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels
- Successful withdrawal of the delivery system
- Patency of all endovascular graft and stent components
- Absence of device deformations requiring unplanned placement of an additional device
- Absence of Type I and III endoleaks at completion angiography
Measured: Up to 30 days
Stent Graft Migratoin
Occurrence of stent graft migration >10 mm
Measured: Up to 5 years
All Endoleaks
Occurrence of endoleaks (all types, including Type I and III)
Measured: Up to 5 years
AAA Enlargement
Occurrence of AAA enlargement
Measured: Up to 5 years
Patency Related Events
Occurrence of patency related events
Measured: Up to 5 years
Device Integrity Failure
Occurrence of device integrity failure
Measured: Up to 5 years
Conversion to Open Repair
Occurrence of Conversion to open repair
Measured: Up to 5 years
Secondary Intervention
Occurrence of Secondary intervention (reason and type)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start17 Feb 2025
- Primary completion15 Sep 2026
- Study completion15 Sep 2026
Why it stopped: Physician-Sponsor Retirment
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 The Cleveland ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Lyden, MD, The Cleveland Clinic
- Investigators
- Sean P Lyden, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657794
- Sponsor's protocol ID
- 25-009
- Acronym
- PMEG
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2024
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT06657794
- Acronym / sponsor ID
- PMEG / 25-009
- Conditions
- Juxtarenal Aortic Aneurysm, Aortic Rupture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Physician-Sponsor Retirment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 24 Oct 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 primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device:
- acutely (i.e., treatment success and technical success);
- at 30 days (i.e., the rate of major adverse events (MAE)); and
- at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Detailed description
The primary objective of the clinical investigation Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft systemImplantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- All patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Patient is ≥ 18 years of age
- Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
- Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
- Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:
Key exclusion criteria (15 listed)
- Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection
- Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
- Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
- Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).
- Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
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 |
|---|---|---|
| Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft systemA Physician Modified Endograft is a commercially available, off-the-shelf endograft that has been altered at the time of the procedure by creating fenestrations in the seal zone of the graft to preserve blood flow into vital branch vessels. These fenestrations are marked with medical grade gold markers to facilitate fluoroscopic visualization during the procedure. In order to prevent branch vessel occlusion, these branch vessels are typically stented with covered balloon expandable stents using standardized techniques. | Device | Intervention |
Primary outcome
Major Adverse Events
Time frame: Up to 30 days
The proportion of patients that experience a rate of Major Adverse Events
Effectiveness
Time frame: Up to 12 months
Technical Success, defined as successful delivery and deployment of the physician modified endovascular graft with preservation of those branch vessels intended to be preserved. * Freedom from Type I \& III endoleaks * Freedom from stent graft migration * Freedom from abdominal aortic aneurysm enlargement * Freedom from Aortic aneurysm rupture and conversion to open repair
9 secondary outcomes
Occurrence of the safety events
Time frame: Up to 5 years
Technical Success
Time frame: Up to 30 days
Stent Graft Migratoin
Time frame: Up to 5 years
All Endoleaks
Time frame: Up to 5 years
AAA Enlargement
Time frame: Up to 5 years
Patency Related Events
Time frame: Up to 5 years
Device Integrity Failure
Time frame: Up to 5 years
Conversion to Open Repair
Time frame: Up to 5 years
Secondary Intervention
Time frame: Up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- 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. This study is not recruiting at the moment.
Sean P Lyden, MD study chair
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system in people with Juxtarenal Aortic Aneurysm and Aortic Rupture, run by The Cleveland Clinic.
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 18 inclusion and 15 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: withdrawn, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events (time frame: Up to 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 9 Oct 2026.