ClinicalTrials.gg
RecruitingNCT07019454Updated Sep 30, 2026

Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms

An interventional study of Physician Modified Endografting in Technical Sucess, Freedom From Type I and III Endoleaks at 12 Months and Freedom From Stent Graft Migration at 12 Months, sponsored by Baystate Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Baystate Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Updated Sep 30, 2026Primary outcomes revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Patients who are found to have an aneurysm (bulge) in the abdominal aorta, which is the blood vessel in your abdomen (belly) that supplies blood to most of your lower body, including major organs and your legs. As an aneurysm expands, the walls of the aorta become weak and may rupture (break open), causing a major loss of blood with a high risk of serious problems and death. To avoid this risk, doctors repair aneurysms by either open surgery (incision) or endovascular surgery (covered stents to channel the blood flow). Juxtarenal aneurysms (those that come close to the kidney arteries) present a unique challenge as they are more dangerous to repair by open therapy and do not fit the standard approved endovascular devices. The purpose of this study is to assess the effects of the physician-modified endovascular graft (PMEG) by collecting information about the performance of this investigational medical device.

The main graft looks like a pair of pants with very short legs. The top of the pants is placed in the aorta. Then, two smaller grafts go from the main graft and to your iliac arteries (the main arteries supplying blood to your abdomen and legs) to form the legs of the pair of pants. Each graft is packed into a small catheter (a long, flexible plastic tube) that is placed into your aorta through the femoral artery in your groin (top of your leg). The grafts are then placed in the correct position in your aorta by releasing them from the catheters. These grafts are investigational because the research physician has changed them to match patient anatomy (body make up) while protecting blood flow to important vessels. Once the grafts are attached inside the aorta, they will support the area of the aorta that is weakened and bulging.

Modifications of the graft will include between one and four holes (fenestrations) near the top of the graft. The holes allow the graft to be located above the renal arteries (the blood vessels that supply blood to your kidneys) without blocking the blood flow to them. One or more of the arteries will also be treated with a stent (metal wire tube) to help keep the arteries open and to keep the arteries connected to the holes that are made for the graft.

The device is custom modified for patient specific anatomy. The information collected from this study will be used to show how well patients do when treated with the modified graft, both immediately after surgery and over a long period of time. After the procedure, labs, CT imaging with contrast, XRays and ultrasounds will be done to check the graft at intervals 1 month, 6 months, 12 months and yearly for 5 years. These are standard surveillance studies performed on any endovascular aneurysm repair.

02

Conditions studied

  • Technical Sucess
  • Freedom From Type I and III Endoleaks at 12 Months
  • Freedom From Stent Graft Migration at 12 Months
  • Freedom From Aortic Aneurysm Enlargement at 12 Months
  • Freedom From Aortic Aneurysm Rupture or Conversion to Open Repair at 12 Months

Keywords

  • complex endovascular aortic aneurysm repair
  • PMEG
  • juxtarenal
03

In context

Aortic Aneurysm

222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.

This study's planned enrollment of 15 is below the median of 62 across 101 interventional studies indexed under Aortic Aneurysm.

Browse Aortic Aneurysm studies →

Lead sponsor

Baystate Medical Center is the lead sponsor of 48 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient is ≥ 18 years of age
  2. 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)
  3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Form
  4. Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:

    1. 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
    2. Aneurysm with a history of growth > 0.5 cm in 6 months
    3. Saccular aneurysm deemed at significant risk for rupture
    4. Symptomatic aneurysm
    5. Ruptured aneurysm
  5. 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.
  6. Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.
  7. 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.
  8. 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.
  9. Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
  10. Patient has juxtarenal aortic neck angulation ≤ 60°
  11. Target branch vessel diameter ≥ 5 mm.
  12. Patient must be willing to comply with all required follow-up exams.

Exclusion criteria

Exclusion Criteria:

  1. Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection
  2. 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)
  3. Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
  4. Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's- Danlos syndrome).
  5. Patient has a known or to anticoagulation or contrast media that is not amenable to pre-treatment.
  6. Patient has known allergy or intolerance to stainless steel, nitiol, or gold (gold-plated tungsten)
  7. Patient has a body habitus that would inhibit X-ray visualization of the aorta
  8. Patient has a limited of less than 1 year
  9. Patient is currently participating in another device or drug clinical trial
  10. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post- treatment procedures and evaluations.
  11. Thrombus or excessive calcification within the neck of the aneurysm
  12. Branch vessel stenosis ≥ 80 %
  13. Patients treatable on label with FDA approved EVAR or FEVAR device and can wait for device availability.
  14. 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.
Terms in these criteria, in plain language(5)

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.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Physician Modified Endograft Group

    Patients in this arm will undergo physician modified endovascular grafting of their juxtarenal aortic aneurysm

    Device: Physician Modified Endografting

Interventions

  • DevicePhysician Modified Endografting

    This is the only intervention in the study

    Also known as: PMEG

06

What researchers measure

Primary outcomes

  1. Percentage patients for which technical success achieved

    The physician was able to insert the delivery catheter and deliver the physician modified endovascular graft to the treatment site and preserve blood flow into the vessels intended to have blood flow preserved.

    Time frame: Periprocedural

  2. Percentage patients with freedom from Type I and III Endoleaks at 12 months

    Yes/No Type I or Type III Endoleak visualized on 12 month CT Angiography

    Time frame: 12 months post-procedure

  3. Percentage of patients with freedom from stent graft migration at 12 months

    Yes/No stent migration at 12 months

    Time frame: 12 months

  4. Percentage of patients with freedom from aortic aneurysm enlargement at 12 months

    Yes/No Freedom from enlargement maximal aortic diameter

    Time frame: 12 months

  5. Percentage of patients with freedom from aortic aneurysm rupture and conversion to open repair through 12 months

    Yes/No freedom from

    Time frame: 12 months

Secondary outcomes

  1. Mortality

    Yes/No

    Time frame: 30 days, 6 months, 12 months, and annually through 5 years

  2. Aneurysm related mortality

    Yes/ No

    Time frame: 30 days, 6 months, 12 months, and annually through 5 years

  3. Aneurysm Rupture

    Yes/ No

    Time frame: 30 days, 6 months, 12 months, and annually through 5 years

  4. Major Adverse Events

    Yes/No

    Time frame: 30 days, 6 months, 12 months, and annually through 5 years

  5. Renal failure with or without permanent dialysis

    Yes/No, with or without dialysis

    Time frame: 30 days, 6 months, 12 months, and annually through 5 years

  6. Graft Infection

    Yes/ No

    Time frame: 30 days, 6 months, 12 months, and annually through 5 years

07

Study locations

1 of 1 sites recruiting
  • Baystate Medical Center
    Springfield, Massachusetts 01199, United States
    Recruiting
    • Erin Daley, MPH, BS · Contacterin.daley2@baystatehealth.org · 413-794-8704
    • Hazel Marecki, MD · Contacthazel.marecki@baystatehealth.org · 413-794-0900
    • Hazel Marecki, MD · Principal investigator
    • Neal Hadro, MD · Sub investigator
    • Marc Norris, MD · Sub investigator
    • Amanda Kravetz, MD · Sub investigator
    • Avery Ching, MD · Sub investigator
    • Matthew Kronick, MD · Sub investigator
    • Mohammad Ali, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: Yes — Unidentified data may be analyzed retrospectively with other hospitals who are conducting this study for data analysis and publication of results.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Over the next several years, maybe 2027 or 2028, share for 2 years

Access criteria: Only site sharing the same protocol, deidentified redcap data

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Jun 2030, 60 months after the start.

Of 44 interventional studies with no phase under Aortic Aneurysm, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 70. This study's planned 60 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 3, 2025
First posted
Jun 13, 2025
StartActual
Jun 3, 2025
Primary completionEst.
Jun 3, 2030
CompletionEst.
Jun 3, 2035
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary outcomes
5 edited
What changed in the outcomes
  • EditedFreedomPercentage patients with freedom from Type I and III Endoleaks at 12 monthsTime frame: 12 months post-procedure
  • EditedFreedomPercentage of patients with freedom from stent graft migration at 12 monthsTime frame: 12 months
  • EditedFreedomPercentage of patients with freedom from aortic aneurysm enlargement at 12 monthsTime frame: 12 months
  • EditedFreedomPercentage of patients with freedom from aortic aneurysm rupture and conversion to open repair through 12 monthsTime frame: 12 months
  • ChangedBefore Technical successNow Percentage patients for which technical success achievedTime frame: Periprocedural
Sep 30, 2026
Secondary outcomes
1 description edited
What changed in the outcomes
  • DescriptionMajor Adverse Events: how it is measured was reworded
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Primary outcomes 5 edited
    What changed in the outcomes
    • EditedFreedomPercentage patients with freedom from Type I and III Endoleaks at 12 monthsTime frame: 12 months post-procedure
    • EditedFreedomPercentage of patients with freedom from stent graft migration at 12 monthsTime frame: 12 months
    • EditedFreedomPercentage of patients with freedom from aortic aneurysm enlargement at 12 monthsTime frame: 12 months
    • EditedFreedomPercentage of patients with freedom from aortic aneurysm rupture and conversion to open repair through 12 monthsTime frame: 12 months
    • ChangedBefore Technical successNow Percentage patients for which technical success achievedTime frame: Periprocedural
    Secondary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionMajor Adverse Events: how it is measured was reworded
    + 3 other changes: index terms, verification date and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07019454
Lead sponsor
Baystate Medical Center
Responsible party
Hazel Marecki, MD (Vascular Surgeon, Baystate Medical Center) — Principal investigator
First posted
Jun 13, 2025
Start date
Jun 3, 2025
Primary completion
Jun 3, 2030 (estimated)
Completion
Jun 3, 2035 (estimated)
Last update
Sep 30, 2026

Study contacts

Erin Daley, MPH, BS
Contact
erin.daley2@baystatehealth.org
413-794-8704
Hazel Marecki, MD
Contact
hazel.marecki@baystatehealth.org
413-794-0900
Hazel Marecki, MD
principal investigator · Baystate Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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