Technical SucessNCT07019454
Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms
A study testing Physician Modified Endografting in people with Technical Sucess and Freedom From Type I and III Endoleaks at 12 Months, run by Baystate Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Technical Sucess, Freedom From Type I and III Endoleaks at 12 Months, Freedom From Stent Graft Migration at 12 Months
- What is being tested?
- Physician Modified Endografting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to 3 Jun 2035
- 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
- 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
- Aneurysm with a history of growth > 0.5 cm in 6 months
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- 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
- 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.
- Patient has known allergy or intolerance to stainless steel, nitiol, or gold (gold-plated tungsten)
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- 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 pre-treatment, required treatment, and post- treatment procedures and evaluations.
- Thrombus or excessive calcification within the neck of the aneurysm
- Branch vessel stenosis ≥ 80 %
- Patients 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.
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
Baystate Medical Center
Springfield, Massachusetts, 01199
Erin Daley, MPH, BS, 413-794-8704, erin.daley2@baystatehealth.org
Hazel Marecki, MD, 413-794-0900, hazel.marecki@baystatehealth.org
About this study
Official title: Baystate Health Physician Sponsored - Investigational Device Exception: Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms
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.
Read more
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.
- Conditions
- 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
- Being tested
- Physician Modified Endografting
- Keywords
- complex endovascular aortic aneurysm repair, PMEG, juxtarenal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician Modified EndograftingDevice
Also called PMEG
This is the only intervention in the study
| Study group | Role | What they receive |
|---|---|---|
| Physician Modified Endograft Group | Experimental | Patients in this arm will undergo physician modified endovascular grafting of their juxtarenal aortic aneurysm Receives: Device: Physician Modified Endografting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural
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
Measured: 12 months post-procedure
Percentage of patients with freedom from stent graft migration at 12 months
Yes/No stent migration at 12 months
Measured: 12 months
Percentage of patients with freedom from aortic aneurysm enlargement at 12 months
Yes/No Freedom from enlargement maximal aortic diameter
Measured: 12 months
Percentage of patients with freedom from aortic aneurysm rupture and conversion to open repair through 12 months
Yes/No freedom from
Measured: 12 months
Secondary outcomes (6)
Mortality
Yes/No
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Aneurysm related mortality
Yes/ No
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Aneurysm Rupture
Yes/ No
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Major Adverse Events
Yes/No
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Renal failure with or without permanent dialysis
Yes/No, with or without dialysis
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Graft Infection
Yes/ No
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start3 Jun 2025
- Primary completion3 Jun 2030 (estimated)
- Study completion3 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Technical SucessStudies of the same condition, open and under way.
- 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
- Model description
- Selected patients based on anatomic criteria will be offered to be included in the study and undergo repair with physician modified endografting only if they are deemed not to be a candidate for an alternative FDA approved endovascular aortic repair device.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazel Marecki, MD, Baystate Medical Center
- Investigators
- Hazel Marecki, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019454
- Sponsor's protocol ID
- 2303212-3
- Other IDs
- G240287
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Unidentified data may be analyzed retrospectively with other hospitals who are conducting this study for data analysis and publication of results.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baystate Health Physician Sponsored - Investigational Device Exception: Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT07019454
- Acronym / sponsor ID
- 2303212-3
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 3 Jun 2030 (estimated)
- Study completion
- 3 Jun 2035 (estimated)
- First posted
- 13 Jun 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Selected patients based on anatomic criteria will be offered to be included in the study and undergo repair with physician modified endografting only if they are deemed not to be a candidate for an alternative FDA approved endovascular aortic repair device.
| Arm | Type | Receives |
|---|---|---|
| Physician Modified Endograft Group | Experimental | Device: Physician Modified EndograftingPatients in this arm will undergo physician modified endovascular grafting of their juxtarenal aortic aneurysm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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.
Key exclusion criteria (14 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 |
|---|---|---|
| Physician Modified EndograftingAlso: PMEGThis is the only intervention in the study | Device | Physician Modified Endograft Group |
Primary outcome
Percentage patients for which technical success achieved
Time frame: Periprocedural
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.
Percentage patients with freedom from Type I and III Endoleaks at 12 months
Time frame: 12 months post-procedure
Yes/No Type I or Type III Endoleak visualized on 12 month CT Angiography
Percentage of patients with freedom from stent graft migration at 12 months
Time frame: 12 months
Yes/No stent migration at 12 months
Percentage of patients with freedom from aortic aneurysm enlargement at 12 months
Time frame: 12 months
Yes/No Freedom from enlargement maximal aortic diameter
Percentage of patients with freedom from aortic aneurysm rupture and conversion to open repair through 12 months
Time frame: 12 months
Yes/No freedom from
6 secondary outcomes
Mortality
Time frame: 30 days, 6 months, 12 months, and annually through 5 years
Aneurysm related mortality
Time frame: 30 days, 6 months, 12 months, and annually through 5 years
Aneurysm Rupture
Time frame: 30 days, 6 months, 12 months, and annually through 5 years
Major Adverse Events
Time frame: 30 days, 6 months, 12 months, and annually through 5 years
Renal failure with or without permanent dialysis
Time frame: 30 days, 6 months, 12 months, and annually through 5 years
Graft Infection
Time frame: 30 days, 6 months, 12 months, and annually through 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 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Unidentified data may be analyzed retrospectively with other hospitals who are conducting this study for data analysis and publication of results.
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.
Hazel Marecki, MD principal investigator
Baystate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician Modified Endografting in people with Technical Sucess and Freedom From Type I and III Endoleaks at 12 Months, run by Baystate Medical Center 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 17 inclusion and 14 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 30 Sep 2026. 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 Erin Daley, MPH, BS (413-794-8704, erin.daley2@baystatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage patients for which technical success achieved (time frame: Periprocedural). The study lists 5 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 30 Sep 2026.