Juxta Renal Abdominal Aortic Aneurysm Without RuptureNCT06834607
Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms
A study testing Physician Modified Aortic Endograft repair for complex aortic aneurysm in people with Juxta Renal Abdominal Aortic Aneurysm Without Rupture and Complex Aortic Aneurysms, run by Akhilesh Jain at 1 site in United States.
Trial summary
The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Juxta Renal Abdominal Aortic Aneurysm Without Rupture, Complex Aortic Aneurysms, Aortic Aneurysm
- What is being tested?
- Physician Modified Aortic Endograft repair for complex aortic aneurysm
- 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
- 1 Jun 2025to 1 May 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
- 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
Show all 17Show fewer
- 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)
Show all 15Show fewer
- 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
Hartford Hospital
Hartford, Connecticut, 06102
Akhilesh K Jain, MD, FACS, FSVS, 860-522-4158, akhilesh.jain@hhchealth.org
Vicky McLeod, 860-972-5799, Vicky.Macleod@hhchealth.org
About this study
The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk candidates for open surgical repair, have limited or no other options for on label treatment with an FDA approved device, and having appropriate anatomy.
Read the detailed description
The primary intent of the study is to assess safety and preliminary effectiveness of the physician modified endografts 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
- Juxta Renal Abdominal Aortic Aneurysm Without Rupture, Complex Aortic Aneurysms, Aortic Aneurysm
- Being tested
- Physician Modified Aortic Endograft repair for complex aortic aneurysm
- Keywords
- Physician Modified Endograft, PMEG, Complex aortic aneurysms, Juxta renal aortic aneurysm
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician Modified Aortic Endograft repair for complex aortic aneurysmDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Device: Physician Modified Aortic Endograft repair for complex aortic aneurysm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Safety of PMEG device will be measured by proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure.
The Primary Safety Endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure.
Major Adverse Events that will be recorded include the following:
- All-cause mortality
- Myocardial Infarction
- Stroke
- Renal Failure
- Respiratory Failure
- Paraplegia
- Bowel Ischemia
- Procedural Blood Loss (> 1000cc)
Measured: 30 days
Primary Effectiveness Endpoint: Will be measured by calculating the proportion of patients that achieve Treatment Success
Effectiveness of the PMEG device will be measured by the calculating the proportion of subjects that achieve Treatment Success.
Treatment Success is a will be assessed at 12 months and is define by a combination of following criteria to be met:
- Technical Success (at the index procedure).
- Freedom from Type I \& 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 and conversion to open repair through 12 months
Technical Success at the index procedure will be defined by: 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: 12 months
Secondary outcomes (2)
Secondary Safety Endpoints: Will be assessed by measuring proportion of patients encountering any of the following adverse events
The adverse events will be evaluated at 30 days, 6 months, 12 months following the initial implant procedure and annually through 5 years.
The adverse events to be evaluated include:
- Mortality
- Aneurysm related mortality
- Aneurysm rupture
- Major Adverse Events (MAE)
- Renal Failure with or without permanent dialysis
- Graft infection
Measured: Through 5 years
Secondary Effectiveness Endpoints: Defined by proportion of patients experiencing the following events.
The secondary effectiveness endpoints will be evaluated at 30 days, 6 months, 12 months following the initial implant procedure and annually through 5 years:
Following secondary endpoints will be evaluated for every patient:
- Technical Success (evaluated at 30-days)
- Stent graft migration (>10 mm)
- All endoleaks, including Type I \& III endoleaks
- AAA enlargement
- Patency related events
- Device integrity failure
- Conversion to open repair
- Secondary intervention (reason and type)
Measured: 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 posted19 Feb 2025
- Study start1 Jun 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juxta Renal Abdominal Aortic Aneurysm Without RuptureStudies 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
- Prospective, single center, nonrandomized, single arm study.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akhilesh Jain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Akhilesh Jain, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834607
- Sponsor's protocol ID
- Ref #: 040115
- Other IDs
- G250012
- Status last verified
- Aug 2025
- First submitted
- 10 Feb 2025
- Last updated
- 24 Aug 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 24 Aug 2025. 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 Complex Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT06834607
- Acronym / sponsor ID
- Ref #: 040115
- Conditions
- Juxta Renal Abdominal Aortic Aneurysm Without Rupture, Complex Aortic Aneurysms, Aortic Aneurysm
- Keywords
- Physician Modified Endograft, PMEG, Complex aortic aneurysms, Juxta renal aortic aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Akhilesh JainUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2032 (estimated)
- First posted
- 19 Feb 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.
The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk candidates for open surgical repair, have limited or no other options for on label treatment with an FDA approved device, and having appropriate anatomy.
Detailed description
The primary intent of the study is to assess safety and preliminary effectiveness of the physician modified endografts 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
- Model description
- Prospective, single center, nonrandomized, single arm study.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Physician Modified Aortic Endograft repair for complex 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 (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 |
|---|---|---|
| Physician Modified Aortic Endograft repair for complex aortic aneurysmTo 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. | Device | Treatment arm |
Primary outcome
Primary Safety Endpoint: Safety of PMEG device will be measured by proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure.
Time frame: 30 days
The Primary Safety Endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure. Major Adverse Events that will be recorded include the following: * All-cause mortality * Myocardial Infarction * Stroke * Renal Failure * Respiratory Failure * Paraplegia * Bowel Ischemia * Procedural Blood Loss (> 1000cc)
Primary Effectiveness Endpoint: Will be measured by calculating the proportion of patients that achieve Treatment Success
Time frame: 12 months
Effectiveness of the PMEG device will be measured by the calculating the proportion of subjects that achieve Treatment Success. Treatment Success is a will be assessed at 12 months and is define by a combination of following criteria to be met: * Technical Success (at the index procedure). * Freedom from Type I \& 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 and conversion to open repair through 12 months Technical Success at the index procedure will be defined by: 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.
2 secondary outcomes
Secondary Safety Endpoints: Will be assessed by measuring proportion of patients encountering any of the following adverse events
Time frame: Through 5 years
Secondary Effectiveness Endpoints: Defined by proportion of patients experiencing the following events.
Time frame: 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 24 Aug 2025.
- Individual participant dataSharing planned: No
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.
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 Aortic Endograft repair for complex aortic aneurysm in people with Juxta Renal Abdominal Aortic Aneurysm Without Rupture and Complex Aortic Aneurysms, run by Akhilesh Jain 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 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: looking for participants now, as of the sponsor's last update on 24 Aug 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 Akhilesh K Jain, MD (860-522-4158, akhilesh.jain@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: Safety of PMEG device will be measured by proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure. (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 24 Aug 2025.